[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrial-fibrillation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrial-fibrillation":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,332,0,25,[9,44,77,109,135,162,189,213,239,261,281,302,332,354,379,400,419,438,459,481,507,526,550,577,596],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100637198","pulsed-field-ablation-for-atrial-fibrillation-using-a-balloon-for-early-intervention---study-100637198",false,"NCT07621003","PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study","PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The \"PULSE - Study\"","PULSE","Inclusion Criteria:\n\n* Adults (≥18 years) with symptomatic or asymptomatic, paroxysmal or persistent atrial fibrillation\n* First diagnosis of AF within the last 36 months\n* At least one documented episode of AF on ECG, Holter monitoring, or eligible Smart Watch Device\n* No prior catheter ablation for AF\n\nExclusion Criteria:\n\n* Persistent AF \\>3 years or longstanding persistent AF\n* Previous AF-Ablation\n* Ongoing continuous AAD therapy with Amiodarone at baseline\n* History of failed continuous AAD therapy with \\> 1 agent. Exceptions are Beta blocker, Verapamil or \"pill in the pocket\"-therapy\n* Left Atrial Volume Index (LAVI) \\> 50mL\u002Fm2\n* Severe mitral regurgitation\n* Contraindications to anticoagulation therapy\n* Severe pulmonary or renal disease\n* Pregnancy, active cancer disease\n* Any condition or disease which is contraindication for AF ablation within 21 days or Anti-Arrhythmic Drug (AAD)","ALL","18 Years",{"count":21,"type":22},264,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is a prospective, multicenter, randomized, open-label, blinded end-point, controlled clinical trial to investigate the impact of first line pulsed field ablation during 12 months follow-up in patients with early-stage paroxysmal or persistent atrial fibrillation (\\\u003C3 years) compared to usual care, defined as OMT.",[28],"Atrial Fibrillation",[30],"Ablation","RECRUITING","2026-08-20",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-08-19",{"date":39,"type":22},"2031-03-31",{"name":41,"class":42},"Asklepios proresearch","INDUSTRY",10,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":18,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100555393","northwestern-tempus-ai-enabled-electrocardiography-notable-trial-100555393","NCT06511505","NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial","NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) Trial: A Pragmatic, Real-world Study of an Artificial-intelligence Enabled Electrocardiogram Algorithms to Improve the Diagnosis of Cardiovascular Disease","NOTABLE","Inclusion Criteria:\n\n1. Atrial fibrillation algorithm\n\n   1. Age 65 or over\n   2. ECG obtained as part of routine clinical care\n2. Structural heart disease algorithm\n\n   1. Age 40 or over\n   2. ECG obtained as part of routine clinical care\n\nExclusion Criteria:\n\n1. Atrial fibrillation algorithm\n\n   1. No history of AF\n   2. No permanent pacemaker (PPM) or implantable cardioverter defibrillator (ICD)\n   3. No recent cardiac surgery (within the preceding 30 days)\n2. Structural heart disease algorithm\n\n   1. No history of SHD\n   2. No echocardiogram within the past 1 year",true,"40 Years",{"count":55,"type":22},1000,[25],"The goal of this clinical trial is to determine if a machine learning\u002Fartificial intelligence (AI)-based electrocardiogram (ECG) algorithm (rECHOmmend and ECG-AF) can identify undiagnosed cardiovascular disease in patients. It will also examine the safety and effectiveness of using this AI-based tool in a clinical setting. The main questions it aims to answer are:\n\n1. Can the AI-based ECG algorithm improve the detection of atrial fibrillation and structural heart disease?\n2. How does the use of this algorithm affect clinical decision-making and patient outcomes?\n\nResearchers will compare the outcomes of healthcare providers who receive the AI-based ECG results to those who do not. Participants (healthcare providers) will:\n\nBe randomized into two groups: one that receives AI-based ECG results and one that does not.\n\nIn the intervention group, receive an assessment of their patient's risk of atrial fibrillation or structural heart disease with each ordered ECG.\n\nDecide whether to perform further clinical evaluation based on the AI-generated risk assessment as part of routine clinical care.",[28,59,60,61],"Cardiovascular Diseases","Arrhythmia","Valvular Disease",[63,64,65,66,67],"early detection","artificial intelligence","structural heart disease","atrial fibrillation","cardiac diagnostics",{"date":32,"type":35},{"date":70,"type":35},"2024-09-16",{"date":72,"type":22},"2028-09",{"name":74,"class":75},"Northwestern University","OTHER",1,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100652936","phase-3-strategies-for-the-management-of-atrial-fibrillation-in-patients-receiving-dialysis-2-safe-d2-100652936","NCT07779746","Strategies for the Management of Atrial Fibrillation in patiEnts Receiving Dialysis 2 (SAFE-D2)","SAFE-D2","Inclusion criteria\n\nTo be eligible to participate in this trial, participants need to satisfy ALL these inclusion criteria:\n\n1. Age ≥18 years,\n2. Kidney failure treated with hemodialysis or peritoneal dialysis for at least 90 days,\n3. A history of non-valvular AF or atrial flutter (AFL) defined as one of the following:\n\n   1. AF\u002FAFL on an ECG at enrollment.\n   2. ≥2 episodes of AF\u002FAFL on cardiac diagnostics with each episode lasting ≥30 seconds and occurring ≥24 hours apart.\n   3. One episode of AF\u002FAFL on cardiac diagnostics lasting ≥30 seconds, plus ≥1 separate documented episode in the medical record.\n   4. One episode of AF (reported by cardiac diagnostics or documented in the medical record) plus treatment with an oral anticoagulant for stroke prevention as a result of AF\u002FAFL; or\n   5. AF\u002FAFL documented on one occasion in a cardiologist report.\n4. Meet the CHA2DS2-VASc criteria (i.e. ≥2 for men and ≥3 for women)\n\nExclusion Criteria\n\nPotential participants must have NONE of the following exclusion criteria:\n\n1. Mitral stenosis described as moderate or severe.\n2. Anticoagulation indicated for a reason other than atrial fibrillation.\n3. Receipt of aspirin at a dose of \\>160 mg daily.\n4. Ongoing requirement at screening for a strong CYP3A4\u002FP-gp inhibitor or inducer that cannot be discontinued, substituted, or otherwise managed safely.\n5. Ongoing requirement for dual antiplatelet therapy at the time of screening that, in the judgement of the treating clinician, is expected to remain necessary after randomization and cannot be safely de-escalated to single antiplatelet therapy in the event of randomization to apixaban.\n6. Known clinically significant coagulopathy, or other bleeding risk that, in the judgment of the treating physician, renders oral anticoagulation unsafe.\n7. A major bleeding event in the 30 days prior to study enrollment, or any active and clinically significant bleeding.\n8. Current pregnancy or breastfeeding.\n9. Anticipated life expectancy \\\u003C 6 months.\n10. A scheduled live donor kidney transplant in the next 6 months.\n11. Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the SAFE-D2 treatment strategies\n12. The treating clinical team has determined that long-term OAC is clearly indicated such that randomization to the no OAC strategy would not be clinically acceptable.\n13. The treating clinical team has determined that long-term OAC is clearly contraindicated such that randomization to the apixaban strategy would not be clinically acceptable.",{"count":85,"type":22},848,[87],"PHASE3","People receiving dialysis are more likely to develop atrial fibrillation (AF), an irregular heartbeat that increases the risk of stroke. Blood-thinning medications (anticoagulants) are commonly used to prevent strokes in people with AF, but it is not known whether they are beneficial for people receiving dialysis because this group has not been well represented in previous clinical trials. As a result, healthcare providers do not have clear evidence to guide treatment decisions.\n\nThe SAFE-D2 study will compare two approaches to preventing stroke in adults receiving maintenance hemodialysis or peritoneal dialysis who have non-valvular AF and are at increased risk of stroke. Participants will be randomly assigned (by chance) to receive either apixaban, an oral blood thinner, or no oral anticoagulant, while continuing to receive their usual dialysis and medical care.\n\nThe main goal of the study is to determine whether apixaban is more effective than no oral anticoagulant at reducing the risk of stroke or blood clots traveling to other parts of the body (systemic embolism). The study will also compare the two approaches with respect to survival, heart-related complications, major bleeding and other bleeding events, hospitalizations, dialysis access complications, quality of life, and the overall balance of benefits and risks.\n\nApproximately 848 participants from Canada, Brazil, and Israel will take part in the study. The results of SAFE-D2 are expected to provide important evidence to help patients, families, and healthcare providers make informed decisions about stroke prevention for people receiving dialysis who have atrial fibrillation.",[28,90,91,92],"Atrial Flutter","End Stage Kidney Disease (ESRD)","Dialysis Patients",[66,94,95,96,97,98,99],"end stage renal disease","end stage kidney disease","dialysis","oral anticoagulation","apixaban","no oral anticoagulation","NOT_YET_RECRUITING","2026-08-18",{"date":34,"type":35},{"date":104,"type":22},"2026-11",{"date":106,"type":22},"2032-11",{"name":108,"class":75},"Unity Health Toronto",{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100514299","early-closure-of-left-atrial-appendage-for-patients-with-atrial-fibrillation-and-ischemic-stroke-despite-anticoagulation-therapy-100514299","NCT05976685","Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy","Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic StrokE Despite Anticoagulation Therapy","ELAPSE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization.\n* Recent (≤3 months) symptomatic ischemic stroke.\n* Active and ongoing anticoagulation therapy at stroke onset assessed based on medical history (i.e. any therapeutic oral anticoagulation therapy \\[Vitamin K antagonist\u002FDOAC according to prescription recommendations for AF; inadequate low-dose DOAC therapy allowed for inclusion\\] not stopped\u002Fpaused for \\>48 hours due to any reason, i.e. medical intervention or non-adherence).\n* Active or planned long-term therapy with DOAC\n\nExclusion Criteria:\n\n* Contraindications to DOAC therapy\n* Life expectancy \\\u003C1 year according to the opinion of the investigator\n* Stroke due to: Ipsilateral intra\u002Fextracranial high-grade stenosis, Isolated lacunar stroke, Other well-defined stroke aetiologies (i.e., endocarditis, vasculitis, Reversible Cerebral Vasoconstriction Syndrome \\[RCVS\\], Posterior Reversible Encephalopathy Syndrome \\[PRES\\], cerebral sinus venous thrombosis)\n* Previous persistent foramen ovale or atrial septum defect closure.\n* Rheumatic heart disease\n* Severe heart valve disease that requires treatment (severe aortic stenosis or regurgitation, severe mitral stenosis or regurgitation).\n* Contraindications for TEE (relevant esophageal varices, esophageal stricture, history of esophageal cancer).\n* Cardiac or non-cardiac surgical procedure within 30 days of randomization\n* Enrolled in another investigation of a cardiovascular device or investigating secondary prevention therapy.\n* Severely reduced Left Ventricular Ejection Fraction (LVEF) \\\u003C30%.\n* Severe renal impairment as described in the summary of medicinal product characteristics for the chosen DOAC (e.g. rivaroxaban, apixaban and edoxaban creatinine clearance \\\u003C15 ml\u002Fmin; dabigatran creatinine clearance \\\u003C30 ml\u002Fmin).\n* Hypertrophic cardiomyopathy\n* Intracardiac tumor\n* Ventricular thrombus\n* Acute cardiac decompensation\n* LAA is obliterated or surgically ligated\n* Persistent proximal LAA thrombus despite 4 weeks of anticoagulation (if a proximal thrombus in the LAA is found, anticoagulation with vitamin K antagonist (INR 2.5-3.5) may be started, and if the thrombus disappears, the patient may be eligible for LAAO)\n* Pregnancy or breastfeeding (pregnancy test in urine or blood to be performed at screening for women of childbearing potential)",{"count":118,"type":22},482,[25],"Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%\u002Fyear. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is \"breakthrough\" cardioembolism (76% of patients) and only a minority of 24% is related to other causes unrelated to AF. Optimal secondary prevention strategy is unknown. The investigators have conducted two independent observational studies including together \\>4000 patients but did not identify any strategy (e.g. switch to different DOAC, additional antiplatelet therapy) that seems superior. A recent randomized controlled trial on surgical occlusion of the left atrial appendage (LAAO) found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation. Triggered by this finding, the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy (DOAC therapy + LAAO) had lower rates of adverse outcomes compared to those with DOAC therapy alone. Therefore, the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy, LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone. The investigators propose an international, multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology. The investigators will use the PROBE design with blinded endpoint assessment. The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset. Patients will be randomized 1:1 to receive LAAO + DOAC therapy (experimental arm) or DOAC therapy alone (standard treatment arm). The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke, systemic embolism and cardiovascular death during follow-up. Secondary outcomes include individual components of the primary composite outcome, safety outcomes (i.e. symptomatic intracranial haemorrhage, major extracranial bleeding, serious device- or procedure-related complication), functional outcome (modified Rankin Scale) and patient-oriented outcomes. The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study, the maximal follow-up will be 48 months. Based on prior observational data from the investigators' group and others (5 observational studies, \\>5000 patients), the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18% in the first year and 9% in the second year (=cumulative 27% after 2 years). A relative risk reduction of 40% at 2 years would be clinically relevant. Based on these assumptions and a log-rank test, the investigators would need 98 events for a power of 80% at an alpha-level of 5%. Assuming a recruitment rate of 52, 118, 156 and 156 patients in years 1 to 4, an additional 6 months of follow-up (mean follow-up time of 2.1 years) and a uniform drop-out rate of 7.5% per year, 482 patients would need to be enrolled. How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma. This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation.",[122,28],"Ischemic Stroke",[124,125,126],"Stroke","Direct oral anticoagulation","Left atrial appendage occlusion",{"date":32,"type":35},{"date":129,"type":35},"2024-05-01",{"date":131,"type":22},"2028-06-01",{"name":133,"class":75},"Insel Gruppe AG, University Hospital Bern",31,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":18,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100503571","phase-3-the-rhythm-evaluation-for-anticoagulation-with-continuous-monitoring-of-atrial-fibrillation-100503571","NCT05836987","The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation","REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation","REACT-AF","Inclusion Criteria:\n\n1. 22-85 years of age.\n2. English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.\n3. History of non-permanent atrial fibrillation.\n4. CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and\u002For ejection fraction \\\u003C 40%.\n5. The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.\n6. Willing and able to comply with the protocol, including:\n\n   * Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan\n   * Be willing to wear the smart watch for the suggested minimum of 14 hours a day\n   * Expected to be within cellular service range at least 80% of the time\n7. Willing and able to discontinue DOAC\n8. The participant is willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Valvular or permanent atrial fibrillation.\n2. Current treatment with warfarin and unwilling or unable to take a DOAC.\n3. The participant is a woman who is pregnant or nursing.\n4. The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration.\n5. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Insertable cardiac monitors are permitted unless they are being used to guide anticoagulation treatment.\n6. Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour\u002Fmonth over the last 3 months.\n7. Any documented single AF episode lasting ≥ 1 hour on standard of care or study-provided external cardiac monitor of \\> 6 days duration performed within 45 days prior to randomization. Shorter monitoring durations may be acceptable for inclusion at the discretion of the site PI based on the totality of monitoring data and approval of the study PI.\n8. Ablation for AF within the last 2 months.\n9. Prior or anticipated left atrial appendage occlusion or ligation.\n10. Mechanical prosthetic valve(s) or severe valve disease.\n11. Hypertrophic cardiomyopathy.\n12. Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve).\n13. Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \\> 75%) based on the investigator's discretion.\n14. The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and\u002For device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.\n15. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.\n16. The participant has a tremor on their ipsilateral side that the AFSW may be worn.\n17. Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).\n18. Known hypersensitivity or contraindication to direct oral anticoagulants.\n19. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.\n20. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.\n21. \\> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.\n22. History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment).\n23. Stage 4 or 5 chronic kidney disease.\n24. Conditions associated with an increased risk of bleeding:\n\n    * Major surgery in the previous month\n    * Planned surgery or intervention in the next three months that would require cessation of anticoagulation \\> 2 weeks.\n    * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding\n    * Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)\n    * Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days\n    * Hemorrhagic disorder or bleeding diathesis\n    * Need for anticoagulant treatment for disorders other than AF\n    * Uncontrolled hypertension (Systolic Blood Pressure \\>180 mmHg and\u002For Diastolic Blood Pressure \\>100 mmHg)","22 Years","85 Years",{"count":146,"type":22},5350,[87],"REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.",[28],[28,151,152,122,153],"Anticoagulation","AF-sensing Smart Watch","Systemic Embolism",{"date":37,"type":35},{"date":156,"type":35},"2023-07-13",{"date":158,"type":22},"2029-07-31",{"name":160,"class":75},"Johns Hopkins University",93,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100494880","carotid-implants-for-prevention-of-stroke-recurrence-from-large-vessel-occlusion-in-atrial-fibrillation-patients-treated-with-oral-anticoagulation-100494880","NCT05723926","Carotid Implants for PreveNtion of STrokE ReCurrEnce From Large Vessel Occlusion in Atrial Fibrillation Patients Treated With Oral Anticoagulation","INTERCEPT","Inclusion Criteria:\n\n1. Documented history of clinical AF\n2. History of ischemic (i.e. non-hemorrhagic) stroke including symptoms of stroke resolving within 24 hours with positive neuro-imaging, meeting one of the following criteria:\n\n   Group 1: Patient was on OAC at time of index stroke, with index stroke occurring \\\u003C 6 week from enrollment Group 2: Patient was not on OAC at time of stroke, with index stroke occurring \\\u003C 6 weeks from enrollment Group 3: Patient was on OAC at time of index stroke, with index stroke occurring 6 to 52 weeks from enrollment\n3. Planned use of a Vitamin K antagonist (VKA) or a direct oral anticoagulant (DOAC) for the duration of the trial\n4. Patient able to tolerate single antiplatelet therapy in addition to oral anticoagulation for 6 months, in the opinion of the investigator\n5. Bilateral ultrasound or angiogram demonstrating all of the following:\n\n   1. Inner common carotid artery diameter range: ≥5.3 mm and ≤8.8 mm\n   2. Accessibility: up to 40 mm from skin to common carotid artery center\n   3. Implantation segment free of any atherosclerotic disease\n   4. Absence of carotid dissection or pre-existing stent(s) in common carotid artery\n   5. Absence of ≥50% stenosis of the internal carotid arteries as seen on ultrasound or angiography (CTA, MRA or DSA)\n\n   i. For ultrasound, calculate the percentage of carotid stenosis using the Society of Radiologists in Ultrasound Consensus Criteria for Carotid Stenosis, where ≥50% stenosis is defined by internal carotid artery peak systolic velocity of ≥125 cm\u002Fsec, internal\u002Fcommon carotid peak systolic velocity ratio of 2 or more and end diastolic velocity of ≥40 cm\u002Fsec, or evidence of near occlusion.\n\n   ii. For angiography, calculate the percentage of carotid stenosis using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria (\\[D - N\\]\u002FD x 100, where N is the luminal diameter at the site of maximal narrowing and D is the diameter of normal distal internal carotid artery beyond the bulb where the artery walls are parallel.\n6. Provision of informed consent\n\nExclusion Criteria:\n\n1. Contraindication to oral anticoagulation (e.g. history of intracranial hemorrhage, known hereditary or acquired coagulation disorders, or recurrent major bleeding)\n2. Contraindication to additional single antiplatelet therapy for 6 months from randomization\n3. Previously documented 50% or greater stenosis, or high-risk plaque in the opinion of the investigator, of the common carotid, internal carotid, subclavian, vertebral, or intracranial arteries that has not been treated with a revascularization procedure (i.e. stent or angioplasty)\n4. Visualized active (acute\u002Fsubacute) cervical or intracranial arterial thrombus (i.e. free-floating) on computed tomography (CT), magnetic resonance (MR), or digital subtraction (DS) angiography that is at risk of causing additional stroke\u002Fbrain injury\n5. Previously documented aneurysm of the internal carotid artery or its branches (i.e. ophthalmic, posterior communicating, anterior choroidal, anterior cerebral and middle cerebral arteries) that is 6 mm or greater in diameter.\n6. Prior surgery or radiation of the neck at the implantation segment\n7. Pre-existing percutaneous left atrial appendage occlusion device that was implanted after most recent ischemic stroke\n8. Planned left atrial appendage occlusion procedure\n9. Female who is pregnant or non-postmenopausal female who is not willing to use an effective method of birth control during duration of the trial\n10. Overt systemic infection\n11. Known sensitivity to nickel or titanium metals, or their alloys\n12. Active participation in another investigational drug or device treatment trial\n13. Any other condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the trial",{"count":170,"type":22},2000,[25],"Patients with atrial fibrillation (AF) who have had a prior stroke are at very high risk of recurrent ischemic stroke. About 40% of these strokes are due to large emboli which result in large cerebral vessel occlusion (LVO). This randomized control trial aims to address this unmet need by testing whether use of bilateral carotid filter implants in addition to OAC will reduce the risk of stroke in AF patients with recent (e.g. within 12 months) ischemic stroke vs. only OAC.",[28,174,124,175],"Oral Anticoagulation","Implant",[177,178,179,180],"Filter","Ischemic stroke","NOAC","LVO",{"date":37,"type":35},{"date":183,"type":35},"2026-01-09",{"date":185,"type":22},"2030-10-20",{"name":187,"class":42},"Javelin Medical",21,{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":18,"minAge":196,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":76},"100652650","phase-4-clinical-impact-of-sglt2-inhibitor-after-dc-cardioversion-in-persistent-af-with-hfpef-100652650","NCT07776054","Clinical Impact of SGLT2 Inhibitor After DC Cardioversion in Persistent AF With HFpEF","Clinical Impact of SGLT2 Inhibitor After DC Cardioversion in Persistent Atrial Fibrillation Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age ≥19 years\n* Persistent atrial fibrillation\n* H2FPEF score ≥6 or HFA-PEFF score ≥5\n* Restoration of sinus rhythm after electrical cardioversion\n\nExclusion Criteria:\n\n* Previous use of an SGLT2 inhibitor\n* Intracardiac thrombus on transesophageal echocardiography\n* Refusal to participate","19 Years",{"count":198,"type":22},200,[200],"PHASE4","SGLT2 inhibitors improve outcomes in heart failure across the ejection fraction spectrum, but their effect on maintenance of sinus rhythm after rhythm-control therapy is largely unknown. This prospective, single-center, open-label randomized controlled trial evaluates whether an SGLT2 inhibitor started after successful electrical cardioversion reduces recurrence of atrial tachyarrhythmia at 1 month in patients with persistent atrial fibrillation and heart failure with preserved ejection fraction. 200 patients will be randomized 1:1 to receive an SGLT2 inhibitor or no SGLT2 inhibitor.",[28,203,204],"SGLT2 Inhibitor","DC Cardioversion","2026-08-17",{"date":32,"type":35},{"date":208,"type":35},"2024-02-01",{"date":210,"type":22},"2027-09-01",{"name":212,"class":75},"Samsung Medical Center",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":23,"phases":223,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":238},"100571113","phase-3-revera-301-etripamil-in-atrial-fibrillation-phase-3-100571113","NCT06716021","ReVeRA-301: Etripamil in Atrial Fibrillation Phase 3","Multi-Center, Placebo-Controlled, Phase 3 Study of Etripamil Nasal Spray (NS) in Patients With Atrial Fibrillation and Rapid Ventricular Rate (RVR)","ReVeRA-301","Inclusion Criteria:\n\n1. Age 18 years and over.\n2. Provision of written informed consent.\n3. Documented history of symptomatic AF (paroxysmal, persistent, or permanent) with a ventricular rate of ≥110 bpm.\n\n   * Documentation: electrocardiogram (ECG) tracing (including 12-lead ECG or ECG strip) showing AF with ventricular rate ≥110 beats per minute (bpm). This ECG documentation (anonymized with study Patient ID only) will be submitted to the Sponsor after screening and prior to randomization to confirm diagnosis of AF with RVR and eligibility to be randomized in the study. Patients who have undergone a prior ablation procedure for AF or for an AF-trigger must have documented AF with RVR post-ablation for study eligibility.\n4. Documented history of repeated (at least 2 within the prior 12 months) and prolonged (at least 20 minutes) symptomatic episodes of AF with elevated (perceived or measured) heart rate (HR).\n\n   * Documentation: Patient description, other history, or medical records. Patients who have undergone a prior ablation procedure for AF or for an AF-trigger must fulfill this criterion post-ablation for study eligibility.\n5. Receiving appropriate antithrombotic\u002Fanticoagulation therapy as per applicable national and\u002For local guidelines for AF management.\n6. Women of childbearing potential must have a negative pregnancy test at Screening and agree to use at least 1 highly effective form of contraception from time of randomization until 7 days after the last administration of study drug and must be willing to discontinue from the study should they become or plan to become pregnant.\n\nExclusion Criteria:\n\n1. Patients with a primary diagnosis of atrial flutter (typical or atypical) or atrial tachycardia. Patients with AF who have been observed to also experience atrial flutter within the same episode (i.e., \"AFib\u002FFlutter\" or an admixture of AF and flutter within the same episode) are eligible.\n2. History of any of the following within the last 6 months: Class 3 or 4 angina per Canadian Cardiovascular Society (CCS) criteria; ischemic chest pain during AF episodes; acute coronary syndrome, unless the patient has been successfully revascularized; coronary artery bypass grafting or open-chest valve surgery.\n3. History of heart failure (HF) New York Heart Association (NYHA) classification ≥Class III within the last 3 months.\n\n   * The etiology of any HF should have been previously evaluated and addressed.\n   * HF with a reduced ejection fraction and\u002For HF with a preserved ejection fraction are acceptable.\n4. History of hemodynamic instability during AF, i.e., symptoms or signs of severe hypotension, or syncope due to a pause upon conversion from AF to sinus rhythm (SR).\n5. History of unexplained syncope.\n6. History of, or ECG evidence at the screening visit, of: sick sinus syndrome, Mobitz II second- or third-degree atrioventricular (AV) block bradycardia (\\\u003C40 bpm) or pauses \\>3 seconds during waking hours, without a pacemaker.\n7. History of, or ECG evidence at the Screening visit, of: torsades de pointes, ventricular fibrillation, or ventricular tachycardia, Brugada syndrome, an antegrade conducting accessory bypass tract (e.g., Wolff-Parkinson-White or Lown-Ganong-Levine syndromes), or long QT syndrome.\n8. History of stroke, transient ischemic attack or peripheral embolism within the last 3 months.\n9. CHA2DS2-VASc score of \\>5.\n10. Planned AF or AV node ablation within the next 3 months.\n11. Uncorrected, severe aortic or mitral stenosis.\n12. Hypertrophic cardiomyopathy with outflow tract obstruction.\n13. History of sensitivity to verapamil or to any components of the investigational product.\n14. History of recent or current chronic alcohol or drug abuse that, in the opinion of the Investigator, could impact the validity of the study results.\n15. Currently participating in another drug or device study, or has received an investigational drug or device within 30 days prior to Screening.\n16. Any other significant co-morbid condition that may negatively impact the patient's participation in the study or likely result in non-compliance.",{"count":222,"type":22},750,[87],"This is a multi-national, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of etripamil NS in patients with atrial fibrillation (AF). This study includes Screening Visit, Randomization Visit, a Treatment Period with scheduled Follow-up Visits (Monthly Follow-up and Post-treatment Follow-up Visits), a Final Study Visit, and an End of Study Telephone Follow up Visit.\n\nEach patient will be randomized 1:1 to receive placebo or 70 mg Etripamil NS regimens. Patients will self-administer study drug for a perceived episode of AF with RVR with an initial dose of placebo or 70 mg etripamil NS, followed by an optional second dose of the same study drug 10 minutes after the first dose if the patient continues to experience symptoms. Patients may treat up to a maximum of 4 episodes in the study.\n\nInformed consent will be obtained prior to any study procedures.",[28],[28,227,228,229],"Rapid Ventricular Rate","Rapid Ventricular Response","Ventricular Rate Control","2026-08-14",{"date":205,"type":35},{"date":233,"type":22},"2027-01",{"date":235,"type":22},"2030-01",{"name":237,"class":75},"Milestone Pharmaceuticals Inc.",2,{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100560512","pulsed-af-post-approval-study-100560512","NCT06578104","PULSED AF Post-Approval Study","PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry","Inclusion Criteria\n\n* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF\n* Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)\n* Patient is ≥ 18 years of age\n* Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System\n* Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements\n\nExclusion Criteria\n\n* Long-standing persistent AF (continuous AF sustained \\>12 months)\n* Prior left atrial catheter or surgical ablation\n* Patient with life expectancy \\\u003C 36 months\n* Presence of a permanent pacemaker, biventricular pacemaker, loop recorder\u002Finsertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)\n* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager",{"count":247,"type":22},580,"OBSERVATIONAL","PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.",[28],"2026-08-11",{"date":253,"type":35},"2026-08-12",{"date":255,"type":35},"2024-11-04",{"date":257,"type":22},"2030-04-30",{"name":259,"class":42},"Medtronic Cardiac Ablation Solutions",23,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":268,"targetDuration":270,"studyType":248,"phases":4,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":280},"100546360","pulseselect-pfa-global-registry-100546360","NCT06393920","PulseSelect™ PFA Global Registry","PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age or minimum age as required by local regulations.\n* Subject has been diagnosed with atrial fibrillation (AF)\n* Planned procedure using commercially available PulseSelect™ PFA System.\n* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.\n\nExclusion Criteria:\n\n* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.\n* Subject with exclusion criteria required by local law.",{"count":269,"type":22},1950,"12 Months","The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.",[28],{"date":274,"type":35},"2026-08-13",{"date":276,"type":35},"2024-07-23",{"date":278,"type":22},"2028-07-31",{"name":259,"class":42},43,{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":76},"100474012","testing-virtues-patient-care-sets-in-cardiac-patients-virtues-cardiac-care-100474012","NCT05452356","Testing VIRTUES Patient Care Sets in Cardiac Patients (VIRTUES Cardiac Care)","Testing of Patient Care Sets and Management of Cardiovascular Conditions Using a Virtual Platform","VIRTUES-CC","Inclusion Criteria:\n\n* Any patient with a cardiovascular condition.\n* Ability to provide informed consent.\n* Proficient in the English language.\n* Access to a device capable of running mobile application.\n* Used mobile technology within the past 3 months.\n\nExclusion Criteria:\n\n* Any medical condition making 1-month survival unlikely.",{"count":170,"type":22},"Patients with various cardiac conditions (such as those who experience a heart attack) are increasing in Canada and are in need of appropriate cardiac rehabilitation and care. Many patients do not have access to local in-person cardiac clinics, particularly in rural regions of Canada. A user-friendly digital application with accessible educational resources and recommendations based on the most up to date clinical practice guidelines can help mitigate these issues. VIRTUES is a digital healthcare application that targets 11 modifiable modules as follows:\n\n1. antithrombotic management\n2. lipid management\n3. rate and rhythm control for atrial fibrillation\n4. heart failure care\n5. post myocardial infarction care\n6. blood sugar management\n7. blood pressure management\n8. physical activity\n9. healthy eating\n10. smoking cessation\n11. alcohol reduction\n\nOf the 11 total modules, the first 7 listed provide recommendations in VIRTUES. The remaining 4 (physical activity, healthy eating, smoking cessation and alcohol reduction) consist of simple referrals to existing recommendations (i.e., for healthy eating and physical exercise) and referrals to existing local programs (i.e., for smoking cessation and alcohol reduction). Thus, in this cohort study, the investigators will test the primary 7 modules with 200 patients per module for approximately one month each in order to obtain feedback on the usability of each module. The investigators will also conduct virtual focus group discussions to obtain open ended feedback on the application. This study will provide valuable feedback, which will be used to improve and adapt the VIRTUES platform.",[292,293,28,59,294],"Heart Diseases","Arrhythmias, Cardiac","Pathologic Processes",{"date":274,"type":35},{"date":297,"type":35},"2024-04-18",{"date":299,"type":22},"2028-09-30",{"name":301,"class":75},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":23,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":4},"100650698","phase-4-ezetimibe-for-arrhythmia-recurrence-after-af-ablation-100650698","NCT07752758","Ezetimibe for Arrhythmia Recurrence After AF Ablation","Ezetimibe for Reducing Atrial Arrhythmia Recurrence After Atrial Fibrillation Ablation: a Prospective Randomized Controlled Pilot Study","EAFA","Inclusion Criteria:\n\n1. Age 18 to 80 years, male or female.\n2. Diagnosis of persistent atrial fibrillation (AF) scheduled for first catheter ablation.\n3. Able to provide written informed consent.\n4. Able to comply with study follow-up and ECG monitoring requirements.\n\nExclusion Criteria:\n\n1. Previous catheter ablation for atrial fibrillation.\n2. Life expectancy \\\u003C12 months due to non-cardiac comorbidities.\n3. Severe valvular heart disease requiring surgery or intervention.\n4. Acute myocardial infarction or stroke within the past 3 months.\n5. Current participation in another investigational drug\u002Fdevice study.\n6. Inability to adhere to study procedures or follow-up.\n7. Pregnancy or breastfeeding (female participants).","80 Years",{"count":312,"type":22},120,[200],"This single-center, prospective, single-blind randomized controlled pilot trial aims to explore whether oral ezetimibe can reduce the 6-month recurrence rate of atrial tachyarrhythmia after catheter ablation in patients with persistent atrial fibrillation. A total of 120 eligible patients will be randomized at a 1:1 ratio into the ezetimibe group and the control group within 24 hours after ablation. Stratified randomization based on body mass index (BMI) and left atrial diameter will be performed via an interactive web response system (IWRS). This study adopts a single-blind design: patients and investigators are unblinded to group allocation, whereas an independent Endpoint Adjudication Committee consisting of three electrophysiologists will blindly review all ECG data to determine arrhythmia recurrence. The intervention group will receive 10 mg oral ezetimibe once daily for six months following ablation, and the use of hobimibe is prohibited in this group. The control group will refrain from the use of both ezetimibe and hobimibe, with standardized postoperative management maintained consistently across the two groups. The primary endpoint is the recurrence of atrial tachyarrhythmia lasting ≥30 seconds after the blanking period within six months post-ablation. Secondary endpoints include early atrial tachyarrhythmia recurrence, atrial fibrillation burden, changes in left atrial diameter, quality of life scores, and composite cardiovascular events. Safety outcomes encompass hepatic and muscular adverse reactions as well as serious adverse events. This prospective pilot study will provide preliminary clinical evidence for optimizing rhythm control strategies after atrial fibrillation catheter ablation.",[28,316],"Post-Catheter Ablation Atrial Arrhythmia Recurrence",[28,318,319,320,321,322],"Catheter Ablation","Ezetimibe","Atrial Arrhythmia Recurrence","Single-Blind RCT","Atrial Remodeling","2026-08-05",{"date":325,"type":35},"2026-08-07",{"date":327,"type":22},"2026-08-15",{"date":329,"type":22},"2028-06-30",{"name":331,"class":75},"Second Affiliated Hospital, Zhejiang University, School of Medicine",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":310,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100633212","a-study-of-varipulse-pulsed-field-ablation-pfa-catheter-and-farawave-pfa-catheter-in-the-treatment-of-participants-with-persistent-atrial-fibrillation-100633212","NCT07523750","A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation","Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial","PERSIGMA RCT","Inclusion criteria:\n\n* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than \\[\\>\\] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days\n* Participant is aged 18 - 80 years at the time of informed consent\n* Participant is willing and capable of providing informed consent\n* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion criteria:\n\n* Participant has continuous AF \\> 365 days (longstanding persistent AF)\n* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)\n* Participant has had previous surgical or catheter ablation for AF\n* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)\n* Participant has severe dilatation of the LA (LAD \\> 50 millimeters \\[mm\\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment\n* Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure\n* Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than \\[\\\u003C\\] 40%) confirmed by imaging performed within 180 days prior to enrollment\n* Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV\n* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)\n* Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment\n* Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment\n* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment\n* Participant has had valvular cardiac surgical\u002Fpercutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)\n* Participant has unstable angina within past 6 months prior to enrollment\n* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure\n* Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Participant has a significant congenital anomaly (for example, atrial septal defects \\[ASDs\\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study\n* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)\n* Participant has a pre-existing hemi-diaphragmatic paralysis\n* Participant has an acute illness, active systemic infection, or sepsis\n* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Participant has severe mitral regurgitation (regurgitant volume greater than or equal to \\[\\>=\\] 60 milliliters \\[mL\\]\u002Fbeat, regurgitant fraction \\>= 50 percent \\[%\\], and\u002For effective regurgitant orifice area \\>= 0.40 square centimeter \\[cm\\^2\\])\n* Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and\u002For a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders \\[ILR\\])\n* Participant has a condition that precludes vascular access (such as inferior vena cava \\[IVC\\] filter)\n* Participant is currently enrolled in an investigational study evaluating another device or drug\n* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation\n* Participant has a life expectancy less than 365 days",{"count":341,"type":22},566,[25],"The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).",[28],"2026-08-03",{"date":323,"type":35},{"date":348,"type":35},"2026-04-02",{"date":350,"type":22},"2028-05-31",{"name":352,"class":42},"Biosense Webster, Inc.",30,{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":367,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":378},"100603652","timing-of-anticoagulation-after-emergency-endovascular-therapy-for-acute-ischemic-stroke-with-atrial-fibrillation-100603652","NCT07139301","Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation","Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation：a Randomised Controlled Trial","TIMERS-1","Inclusion Criteria:\n\n1. Aged 18 years or over.\n2. Clinical diagnosis of large vessel occlusion acute ischemic stroke.\n3. Emergency endovascular treatment was performed within 24 hours of stroke onset.\n4. Atrial fibrillation (including paroxysmal, persistent or permanent atrial fibrillation), confirmed by at least one of the following:\n\n   1. 12-lead ECG recording\n   2. Inpatient ECG telemetry\n   3. Prolonged ECG monitoring (e.g. Holter monitor)\n   4. Previously established diagnosis of atrial fibrillation verified by medical records.\n5. CT or MRI demonstrating one of the following findings:\n\n   1. No hemorrhagic transformation;\n   2. Hemorrhagic infarction type 1 (HI1), defined as small petechiae along the margins of the infarct (Heidelberg classification);\n   3. Hemorrhagic infarction type 2 (HI2), defined as confluent petechiae within the infarcted area without space-occupying effect (Heidelberg classification).\n6. Time from stroke onset to randomization was within 72 hours.\n7. Written informed consent obtained from the patient or a legally authorized representative.\n\nExclusion Criteria:\n\n1. Atrial fibrillation due to reversible causes (e.g. thyrotoxicosis, pericarditis, recent surgery, or myocardial infarct).\n2. Contraindication to the use of direct oral anticoagulants (DOACs):\n\n   1. Known allergy or intolerance to both factor Xa inhibitors and direct thrombin inhibitors;\n   2. Definite indication for vitamin K antagonist (VKA) treatment (e.g. mechanical heart valve, valvular atrial fibrillation);\n   3. Severe renal impairment (defined as creatinine exceeding 1.5 times of the upper limit of normal range) and significant hepatic dysfunction (defined as ALT or AST \\> twice the upper limit of normal range) ;\n   4. Concomitant use of medications with significant interactions with DOACs, including azole antifungals, HIV protease inhibitors, or strong CYP3A4 inducers;\n   5. Baseline platelet count \\\u003C 100 x 109\u002FL;\n   6. History of coagulopathy or systemic hemorrhage.\n3. Prior DOAC use within 48 hours of stroke onset, or recent treatment with vitamin K antagonist (VKA) leading to INR ≥1.7 at randomization.\n4. Pregnant or breastfeeding women, or positive pregnancy test at admission.\n5. History of major surgery or severe trauma within 1 month prior to stroke onset.\n6. History of active bleeding within 1 month prior to stroke onset (e.g. gastrointestinal bleeding, urinary tract bleeding).\n7. Dual antiplatelet therapy at baseline, or strong likelihood of requiring dual antiplatelet therapy during the trial.\n8. Evidence of cerebral amyloid angiopathy.\n9. CT or MRI evidence of non-stroke pathology likely to account for the presenting clinical symptoms (e.g. mass lesion, encephalitis).\n10. Modified Rankin scale (mRS) score \\> 1 prior to stroke onset.\n11. Inability to complete the 90-day follow-up.\n12. Currently participating in another drug clinical trial.\n13. Any other reason deemed by the investigator to make the patient unsuitable for participation in the trial.",{"count":363,"type":22},438,[25],"This study evaluates the safety and efficacy of early versus delayed initiation of direct oral anticoagulants (DOACs) in patients with acute ischemic stroke related to atrial fibrillation after emergency endovascular therapy (EVT).",[122,28],[368,125,369,370,124],"Endovascular Therapy","Therapy initiation","Randomized Controlled Trial",{"date":323,"type":35},{"date":373,"type":35},"2025-09-04",{"date":375,"type":22},"2026-08-31",{"name":377,"class":75},"Capital Medical University",40,{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":310,"enrollmentInfo":387,"targetDuration":4,"studyType":23,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":396,"leadSponsor":398,"locationsCount":399},"100633485","a-study-of-varipulse-catheter-in-participants-with-persistent-atrial-fibrillation-undergoing-pulmonary-vein-and-superior-vena-cava-isolation-100633485","NCT07527299","A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation","Assessment of the Safety and Effectiveness of the VARIPULSE™ Catheter System in the Treatment of Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein (With or Without Posterior Wall Isolation) and Superior Vena Cava Isolation: A Randomized Controlled Trial","SPAA PFA","Inclusion criteria:\n\n* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days in duration and less than 365 days in duration, documented by: i. A physician's note documenting diagnosis of symptomatic PsAF, as defined above; and ii. Two electrocardiograms (ECGs) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than (\\>) 365 days prior to enrollment); or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days\n* Participant is aged 18 - 80 years at the time of informed consent\n* Participant is willing and capable of providing informed consent\n* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirement\n\nLeft atrial appendage occlusion (LAAO) concomitant subset:\n\n\\- Participant is clinically indicated for a LAAO procedure\n\nExclusion criteria:\n\n* Participant has continuous AF \\> 365 days (longstanding persistent AF)\n* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)\n* Participant has had previous surgical or catheter ablation for AF\n* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)\n* Participant has LA (left atrial) anteroposterior \\>= 55 millimeter (mm) (by magnetic resonance imaging \\[MRI\\], computed tomography \\[CT\\], or transthoracic echocardiogram \\[TTE\\]), or if LA diameter is not available, non-index volume \\>100 milliliter (mL) confirmed within 365 days prior to enrollment\n* Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure\n* Participant has severely compromised left ventricular ejection fraction (left ventricle ejection fraction \\[LVEF\\] less than \\[\\\u003C\\] 40 percent \\[%\\]) confirmed by imaging performed within 180 days prior to enrollment\n* Participant has uncontrolled heart failure or New York heart association (NYHA) Class III or IV functional classification\n* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)\n* Participant has had a thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 180 days prior to enrollment\n* Participant has had a percutaneous coronary intervention or acute myocardial infarction (MI) within past 60 days prior to enrollment\n* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment\n* Participant has had valvular cardiac surgical\u002Fpercutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)\n* Participant has unstable angina within past 6 months prior to enrollment\n* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure\n* Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Participant has a significant congenital anomaly (for example, atrial septal defects \\[ASDs\\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study\n* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)\n* Participant has a pre-existing hemi-diaphragmatic paralysis\n* Participant has an acute illness, active systemic infection, or sepsis\n* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Participant has severe mitral regurgitation (Regurgitant volume greater than or equal to \\[\\>=\\] 60 milliliters \\[mL\\]\u002Fbeat, Regurgitant fraction \\>= 50%, and\u002For Effective regurgitant orifice area \\>= 0.40 square centimeter \\[cm\\^2\\])\n* Participants with an implanted metal cardiac device that may interfere with the pulsed field energy field are excluded, including but not limited to: -MitraClip, -LAAO devices (for example, WATCHMAN, Amulet), -Double-coiled implantable cardioverter-defibrillators (ICDs). This exclusion does not apply to participants with any of the following devices: -Coronary stents, -Implanted pacemakers, -Single-coiled ICDs, -Implantable loop recorders (ILRs)\n* Participant has a condition that precludes vascular access (such as inferior vena cava \\[IVC\\] filter) - Participant is currently enrolled in an investigational study evaluating another device or drug\n* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation\n* Participant has a life expectancy of less than 365 days\n* Participant has contraindications for the devices used in the study, as indicated in the respective instructions for use (IFUs)\n* Participant has contraindications for the ablation of the SVC\n\nLAAO concomitant subset:\n\n* Participant is contraindicated for a LAAO procedure per the instructions of use of the planned LAAO device\n* Participant with prior LAAO procedure (attempted or successful)",{"count":388,"type":22},1070,[25],"The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \\[PVI\\] and superior vena cava isolation \\[SVCI\\]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.",[28],"2026-07-30",{"date":394,"type":35},"2026-07-31",{"date":323,"type":22},{"date":397,"type":22},"2031-08-04",{"name":352,"class":42},27,{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":310,"enrollmentInfo":408,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":4},"100632244","a-study-of-varipulse-catheter-in-participants-with-paroxysmal-atrial-fibrillation-under-optimized-sedation-100632244","NCT07511166","A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation","High-quality Pulmonary Veins Isolation Using Varipulse Catheter Under Contact and Continuity Guidance in Patients With Paroxysmal Atrial Fibrillation Under Optimized Sedation","GreatPFA","Inclusion criteria:\n\n* Diagnosed with I and\u002For III antiarrhythmic drugs (AAD)-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and\u002For III AAD based on medical records\n* Age 18-80 years\n* Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements\n* Signed patient informed consent form (ICF)\n\nExclusion criteria:\n\n* Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause\n* Previous left atrium (LA) ablation or surgery\n* Left atrium diameter (LAD) greater than (\\>) 50 millimeters (mm) by transthoracic echocardiography (TTE)\n* Left ventricular ejection fraction (LVEF) less than (\\\u003C) 40 percent (%)\n* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study\n* Current enrollment in an investigational study evaluating another device or drug\n* Women who are pregnant (as evidenced by pregnancy test or oral confirmation if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Life expectancy less than 12 months\n* Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)\n* Presenting contra-indications for catheter ablation at physicians' discretion, for example LA\u002FLeft atrial appendage (LAA) thrombus, systematic infection, situations preventing catheter access\n* Other conditions that, at discretion of the investigators, would preclude enrollment in this study",{"count":409,"type":22},300,"The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).",[28],{"date":394,"type":35},{"date":414,"type":22},"2026-09-07",{"date":416,"type":22},"2028-07-28",{"name":418,"class":42},"Johnson & Johnson Medical (Shanghai) Ltd.",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":18,"minAge":143,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":260},"100610434","a-study-assessing-long-term-safety-and-effectiveness-in-treatment-management-of-atrial-fibrillation-with-varipulse-catheter-system-100610434","NCT07227532","A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System","BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System","AdmIREPAS","Inclusion Criteria:\n\n* Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF\n* Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I\u002FIII antiarrhythmic drugs (AAD)\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Previously diagnosed with persistent or long-standing persistent AF (more than \\[\\>\\] 7 days in duration)\n* Previous surgical or catheter ablation for AF\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF\n* Current enrollment in an investigational study evaluating another device or drug\n* Life expectancy less than 12 months\n* Any contraindications as defined in the Protocol",{"count":428,"type":22},276,[25],"The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).",[28],{"date":394,"type":35},{"date":434,"type":35},"2025-10-21",{"date":436,"type":22},"2030-12-31",{"name":352,"class":42},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":144,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":455,"leadSponsor":457,"locationsCount":399},"100637645","phase-2-a-study-to-test-how-well-bay-3670549-works-and-how-safe-it-is-in-patients-with-atrial-fibrillation-100637645","NCT07625215","A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation","A Placebo-controlled, Parallel-group, Double Blind, Randomized, Multi-cohort Phase 2 Study to Investigate Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BAY 3670549 in Adult Participants With Atrial Fibrillation.","CARDIOVERT","Inclusion Criteria:\n\n* Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent.\n* Participant is hemodynamically stable and does not require emergency cardioversion, as determined by the investigator.\n* Participant has a current episode of atrial fibrillation (AF) ongoing for at least 3 hours and no more than 30 days at the time of randomization.\n* Participant has an indication for electrical cardioversion of AF, as determined by the investigator according to standard clinical practice and national\u002Finstitutional guidelines.\n* At randomization, successful initiation and achievement of therapeutic levels of anticoagulation therapy, as well as completion of imaging evaluation for left atrial thrombi, as appropriate for the duration of the AF episode and risk for the participant according to national guideline and institution-specific routine practice.\n* BMI within range \\[18 - 39.9\\] kg\u002Fm2.\n* Contraceptive use by participants or participant partners should be consistent with the study protocol and local regulations regarding the methods of contraception for those participating in clinical studies.\n* Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n* Willing and able to comply with the receipt, home use, and return of the continuous ECG recording device, as well as with the participation in scheduled telephone follow-up assessments.\n\nExclusion Criteria:\n\n* Current atrial flutter (AFL) or combined AF\u002FAFL\n* Contraindication for electrical cardioversion on planned treatment day\n* Documented severely dilated left atrium (left atrial diameter, LAD \\>5 cm) measured by any modality within the 6 months prior to screening; if several values are available, the most recent one shall be reported. If left atrium diameter was not measured in the last 6 months or a major cardiovascular event occurred within the last 6 months, a new measurement must be done at screening\n* Unsuccessful conversion of current AF episode (pharmacologically or electrically)\n* Known severe valvular heart disease (e.g., severe mitral regurgitation, severe aortic stenosis)\n* Patients with NYHA Class ≥ III heart failure, or with active management of acute heart failure decompensation on treatment day.\n* History within the preceding 3 months prior to randomization of any of the following events, or any other significant cardiovascular event as judged by the investigator:\n\n  * Stroke\n  * Myocardial infarction\n  * Unstable angina pectoris or other signs of myocardial ischemia\n  * Cardiac surgery\n  * Transcatheter valve replacement\n  * Percutaneous coronary intervention (PCI)\n  * Coronary artery bypass graft (CABG) or other revascularization procedure\n* Severe renal impairment, i.e., estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m² (using CKD-EPI formula) or requiring dialysis\n* Severe hepatic impairment, i.e. Child Pugh Class C\n* Use of anti-arrhythmic class I or III drugs within 5 half-lives before study drug administration (oral amiodarone in the previous 3 months)\n* Hypertension with SBP ≥ 180 mmHg or hypotension (SBP \\\u003C 90 mmHg) at randomization (based on the second BP measurement)\n* Stressor-associated AF, i.e., in the setting of an acute and reversible stressor (e.g., cardiac surgery, myocarditis, endocarditis, sepsis, pneumonia, etc.). This includes ablation procedure within the preceding one month prior to randomization.",{"count":447,"type":22},360,[449],"PHASE2","The main goal of this study is to find out how well BAY 3670549 works, how safe it is, how well people can tolerate it, and how the body handles the medicine. The study will compare BAY 3670549 to a placebo (a dummy treatment with no active medicine) in people with AF who need a treatment called electrical cardioversion.\n\nElectrical cardioversion is a procedure that helps the heart return to a normal rhythm. In this study, each participant will get a single intravenous (IV) infusion of either BAY 3670549 or a placebo. Participants will then be observed to see whether the heart rhythm returns to a normal rhythm. If it does not, electrical cardioversion can still be performed as planned. The study will look at how many participants return from AF to a normal rhythm, without needing electrical cardioversion and how long it takes. It will also show how many participants experience medical problems after treatment and how BAY 3670549 move into, through and out of the participants' body.\n\nThe total duration of the study for an individual participant may be up two months.\n\nThe findings from this study may contribute to the development of a new treatment option for people with AF.",[28],"2026-07-29",{"date":392,"type":35},{"date":375,"type":22},{"date":456,"type":22},"2030-05-16",{"name":458,"class":42},"Bayer",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":469,"conditions":470,"keywords":471,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":378},"100609629","phase-2-a-study-to-investigate-the-efficacy-safety-tolerability-and-pharmacokinetics-of-pkn605-in-participants-with-atrial-fibrillation-100609629","NCT07217067","A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation","A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation Burden (AFB) as Well as the Safety, Tolerability, and Pharmacokinetics of Oral PKN605 in Participants With Atrial Fibrillation","Inclusion Criteria:\n\n* Inclusions at Screening\n\n  * Signed informed consent must be obtained prior to participation in the study\n  * Male and female participants ≥ 18 years of age\n  * History of at least 2 episodes of AF (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrillation\n  * At least 1 of the AF episodes specified in inclusion #3 must be within the last 12 months (or during screening) and documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator\n  * One or more of the following:\n* AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months\n* CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)\n* Stable heart failure or with New York Heart Association class I or II symptoms\n* NT-proBNP level of 300 pg\u002FmL or higher on a local lab test within the last 12 months\n\n  * On guideline-directed stroke prevention treatment, as confirmed by the Investigator\n  * Participants must have a body mass index (BMI) ≥ 18 kg\u002Fm2. BMI is calculated as body weight (kg) divided by height (m) squared\n* Inclusions at Day 1\n\n  * Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)\n\nExclusion Criteria:\n\n-Exclusions at Screening\n\n* Permanent AF\n* Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)\n* Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)\n* History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation.\n* Implanted pacemaker, defibrillator, or cardiac monitor\n* Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy\n* Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used\n* Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening",{"count":467,"type":22},165,[449],"A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation",[28],[472,473,60],"Atrial fibrillation","Atrial fibrillation burden",{"date":394,"type":35},{"date":476,"type":35},"2025-10-28",{"date":478,"type":22},"2027-09-09",{"name":480,"class":42},"Novartis Pharmaceuticals",{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":52,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":488,"conditions":489,"keywords":498,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":76},"100599224","longitudinal-validation-of-circ-technologies-100599224","NCT07081711","Longitudinal Validation of CIRC Technologies","Inclusion Criteria:\n\n* Age ≥ 18 years of age\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Vulnerable populations will be excluded from this study including Prisoners\n* Other contraindications to CMR imaging to be determined by standard MRI protocols\n* Decisionally impaired (e.g., dementia or cognitive disability)",{"count":55,"type":22},"Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Moreover, the intrinsic advantage of MRI's lack of exposure to ionizing radiation is particularly beneficial. At the same time, blood work can be very useful in early detection of certain cardiomyopathy, such as amyloid. However, there is a lack of agreement of on which markers are the most sensitive. This multi-study will allow the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases.\n\nThe study team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In this study, the investigators aim to further study the importance of cardiac microstructure revealed by MRI in patient and healthy population and compare this novel technology with conventional clinical biomarkers.",[59,490,491,492,493,494,495,496,28,497],"Heart Failure","Ischemic Heart Disease","Non-ischemic Cardiomyopathy","Valvular Heart Disease","Metabolic Cardiomyopathy","Congenital Heart Disease","Aortic Diseases","Ventricular Fibrillation",[499],"MRI",{"date":394,"type":35},{"date":502,"type":35},"2026-05-06",{"date":504,"type":22},"2037-08",{"name":506,"class":75},"The Cleveland Clinic",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":76},"100613716","mcg-in-long-qt-syndrome-100613716","NCT07270211","MCG In Long QT Syndrome","Magnetocardiography in Long QT Syndrome: A Prospective Study of Its Clinical and Prognostic Utility","Inclusion Criteria\n\n1. Age ≥ 18 years on the date of consent\n2. Ability for participant to comply with study requirements\n3. Written informed consent\n4. Confirmed diagnosis of atrial fibrillation and receiving dofetilide for rhythm control in the inpatient setting.\n\nExclusion Criteria\n\n1. Pregnant or breastfeeding\n2. Active thoracic metal implants (including pacemaker, insertable cardiac monitor, or internal defibrillators).\n3. External electrical pads or devices (e.g. Pacer pads, ECG electrodes, heart rate patch), that must remain on patient's chest during MCG scan\n4. Inability to lie down in a supine\u002Finclined position and stay still on the examination bed\n5. Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol",{"count":515,"type":22},100,"The primary objective of this observational study is to evaluate whether magnetocardiography (MCG) findings more accurately predict clinical outcomes in patients with acquired Long QT syndrome compared to ECG. The secondary objective is to assess differences in QT interval length between MCG and ECG. The primary safety objective is to characterize the safety profile of the CardiAQ MCG device.",[28],"2026-07-28",{"date":452,"type":35},{"date":521,"type":22},"2026-09",{"date":523,"type":22},"2027-12",{"name":525,"class":75},"Mayo Clinic",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":310,"enrollmentInfo":534,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":76},"100468304","doac-in-chinese-patients-with-atrial-fibrillation-100468304","NCT05378035","DOAC in Chinese Patients With Atrial Fibrillation","Direct Oral Anticoagulant Levels in Chinese Patients With Atrial Fibrillation - A Real- World Pharmacokinetic Study","DOAC-REAL","Inclusion Criteria:\n\n* Chinese nonvalvular atrial fibrillation (NVAF) patients on apixaban, dabigatran, edoxaban, or rivaroxaban for 6 months or more.\n* Patients aged 18-80 years old.\n* Patients who are able to provide an informed consent.\n* Patients who are indicated for elective medical procedures that require interruption of direct oral anticoagulants (DOAC) for 48 hours.\n\nExclusion Criteria:\n\n* Patients who developed thromboembolism (e.g. ischemic stroke, ischemic bowel, etc.) or major systemic bleeding (e.g. intracerebral haemorrhage, gastrointestinal bleeding) during DOAC usage.\n* Patients with creatinine clearance by Cockroft-Gault formula ≤ 30 mL\u002Fmin.\n* Patients with inappropriate DOAC dosages with respect to age, body weight, and creatinine clearance.\n* Patients who receive DOAC with indications other than NVAF, such as history of mitral stenosis, metallic heart valve, thrombophilia, venous thromboembolism, etc.\n* Patients with conditions that alter haemostasis besides DOAC use, such as essential thrombocytosis, hepatic congestion, hepatic failure with coagulopathy, etc.",{"count":535,"type":22},427,"Direct oral anticoagulants (DOACs) have emerged as safe and efficacious ischemic stroke prophylaxis for non-valvular atrial fibrillation (NVAF). All four DOACs - apixaban, dabigatran, edoxaban, and rivaroxaban - were shown to reduce the risk of major bleeding compared to warfarin. The predictable pharmacokinetic profiles of DOACs also favour their use over warfarin. Together with increasing AF incidence due to population ageing, increased AF detection, and territory-wide reimbursement schemes, DOAC prescriptions have been surging worldwide. In Hong Kong, more than 78,354 patients received DOAC from January 2009 through April 2021 according to the Hospital Authority registry.\n\nThe more liberal use of DOACs has led to new issues that require a thorough understanding of ethnic-specific DOAC pharmacokinetic profiles. For instance, 12- 15% of anticoagulated patients annually required interventional procedures that involve temporary discontinuation of DOAC for 48 hours or more. Although guideline-based periprocedural DOAC interruption resulted in a low 30-day thromboembolism rate of 0.16% - 0.6% in a Caucasian cohort, same measures for elective colonoscopies in a local population-based study resulted in a 30-day periprocedural thromboembolism rate of up to 2.2%. Although these studies cannot be compared directly, the remarkable interethnic discrepancy between the two cohorts warrants further pharmacokinetic and pharmacogenomic studies. More importantly, quantifying residual DOAC levels during the interruption periods may imply on duration of periprocedural DOAC interruption, length of hospital-stay, and the risk of thromboembolic and bleeding complications.\n\nMapping inter- and intra-individual variations in DOAC levels may also impact on the management of ischemic stroke among DOAC recipients. Epidemiological studies have shown alarmingly up to 13% of acute ischemic stroke patients were on anticoagulation prior to stroke onset with increasing number of DOAC. These patients received low rates of recanalization therapy due to apprehension of bleeding complications, thus compromised survival and neurological recovery. A prospective study that reveals Asian-specific DOAC pharmacokinetic profiles may inform cross-disciplinary, territory-wide periprocedural care and acute stroke intervention strategy for the rapidly expanding DOAC population.",[28,124,538,539,540,541,542],"Stroke, Acute","Brain Diseases","Major Adverse Cardiovascular Event","Arterial Thromboembolism","Venous Thromboembolism",{"date":392,"type":35},{"date":545,"type":35},"2022-09-28",{"date":547,"type":22},"2027-12-31",{"name":549,"class":75},"Chinese University of Hong Kong",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":23,"phases":560,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":4},"100636050","phase-2-restoring-sinus-rhythm-using-dual-shock-technique-in-patients-with-atrial-fibrillation-100636050","NCT07560644","Restoring Sinus Rhythm Using Dual-Shock Technique in Patients With Atrial Fibrillation","Restoring Sinus Rhythm Using DUAL-electrical SHOCK Technique: the DUAL-SHOCK Trial","DUAL-SHOCK","Inclusion Criteria:\n\n* Diagnosis of persistent AF.\n* Effective anticoagulation for at least 3 weeks prior to the procedure or exclusion of intra-atrial thrombus by transesophageal echocardiography within the last 24 hours.\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Long-standing persistent atrial fibrillation (more than 1 year of uninterrupted AF rhythm).\n* Emergency indication (hemodynamic instability).\n* Cardiac defibrillation following catheter ablation procedures. Cardiac defibrillation performed during the same procedure will be permitted if it is carried out prior to ablation.\n* Pregnancy.\n* Age \\\u003C18 years or legal incapacity.",{"count":559,"type":22},177,[449,87],"The goal of this clinical trial is to assess the efficacy and acute safety of the dual electrical cardioversion (ECV) technique compared with the conventional ECV in patients with persistent atrial fibrillation. The main question it aims to answer are:\n\n* Is dual ECV more effective than conventional ECV to achieve sinus rhythm restoration?\n* Is dual ECV safe compared with conventional ECV?\n* Which are the main factors associated with cardioversion success?\n\nResearchers will compare a dual ECV technique with 400J with dual ECV with 200J and conventional ECV.\n\nParticipants will be randomized to one ECV configuration. The primary efficacy endpoint will be considered the percentage of patients with successful cardioversion with the first shock. The coprimary safety endpoint will be the occurrence of adverse events during ECV.",[563,28],"Atrial Fibrillation (AF)",[472,565,566,567,568],"Persistant atrial fibrillation","Electrical Cardioversion","Dual-Shock","Sinus Rhythm","2026-07-25",{"date":518,"type":35},{"date":572,"type":22},"2026-08-01",{"date":574,"type":22},"2028-02-27",{"name":576,"class":75},"Martín Negreira Caamaño, MD, PhD",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":583,"maxAge":310,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":591,"leadSponsor":593,"locationsCount":595},"100630811","novel-model-of-integrated-care-of-older-patients-with-atrial-fibrillation-and-heart-failure-in-rural-china-miracle-afhf-100630811","NCT07492524","Novel Model of Integrated Care of Older Patients With Atrial Fibrillation and Heart Failure in Rural China (MIRACLE-AFHF)","1\\. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. Patients are eligible for participation if 1)they aged 65-80 years. 2) Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist. 3) A documented history of HF or a diagnosis of HF based on echocardiography and\u002For NT-proBNP screening, defined by the presence of typical HF symptoms and\u002For signs, together with one of the following: reduced left ventricular ejection fraction (HFrEF; LVEF \\\u003C 40%), mildly reduced left ventricular ejection fraction (HFmrEF; LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease changes (HFpEF; LVEF ≥ 50%, meeting at least one of the following criteria: LAV 40 ml\u002Fm², E\u002Fe' ≥ 15, or TRV \\> 2.8 m\u002Fs). 4) Management by a village clinic near the participant's place of residence. 5) Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n1. Expected life expectancy of less than 12 months.\n2. Severe renal insufficiency (Ccr \\\u003C 30ml\u002Fmin) or ongoing dialysis treatment.\n3. Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.\n4. Indications for pacemaker implantation without having undergone implantation.\n5. Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure.\n6. Special populations, including patients with mental illnesses.","65 Years",{"count":585,"type":22},942,[25],"This cluster randomization study aims to compare village-doctor led integrated care versus usual care to improve heart failure risk management, guideline-directed medical therapy, self-management adherence, and clinical outcomes for older patients with atrial fibrillation and heart failure in rural China.",[28,490],{"date":518,"type":35},{"date":572,"type":22},{"date":592,"type":22},"2029-12-30",{"name":594,"class":75},"Jiangsu Taizhou People's Hospital",3,{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":18,"minAge":583,"maxAge":310,"enrollmentInfo":602,"targetDuration":4,"studyType":23,"phases":604,"briefSummary":605,"conditions":606,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":607,"startDateStruct":608,"completionDateStruct":609,"leadSponsor":611,"locationsCount":595},"100630809","novel-model-of-integrated-care-of-older-patients-with-atrial-fibrillation-to-prevent-heart-failure-in-rural-china-100630809","NCT07492498","Novel Model of Integrated Care of Older Patients With Atrial Fibrillation to Prevent Heart Failure in Rural China","Inclusion Criteria:\n\n1\\. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. Patients are eligible for participation if 1)they aged 65-80 years.\n\n2)Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist.\n\n3)Receiving healthcare management from a primary medical institution near the place of residence.\n\n4)Able to understand and sign the informed consent form.\n\nExclusion Criteria:\n\n1. A definite history of heart failure, or confirmed cardiac dysfunction or heart failure based on echocardiography and\u002For NT-proBNP screening. Diagnostic criteria include typical heart failure symptoms or signs with reduced left ventricular ejection fraction (HFrEF, LVEF \\\u003C40%), mildly reduced left ventricular ejection fraction (HFmrEF, LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease evidence (HFpEF, LVEF ≥50%, with at least one of the following: LAVI \\>40 mL\u002Fm², E\u002Fe' ≥15, or TRV \\>2.8 m\u002Fs).\n2. Expected survival of less than 12 months.\n3. Severe renal insufficiency, defined as creatinine clearance \\\u003C30 mL\u002Fmin, or currently receiving dialysis treatment.\n4. Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.\n5. Indication for pacemaker implantation but without pacemaker placement.\n6. Chronic obstructive pulmonary disease complicated by type II respiratory failure.\n7. Special populations, such as patients with mental illness.",{"count":603,"type":22},1356,[25],"This cluster randomized study aims to compare village doctor-led integrated care versus usual care to improve cardiovascular health, atrial fibrillation management, self-management adherence, and heart failure prevention among older rural patients with atrial fibrillation in China.",[28,490],{"date":518,"type":35},{"date":572,"type":22},{"date":610,"type":22},"2030-07-01",{"name":594,"class":75}]