[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrial-fibrillation-af\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrial-fibrillation-af":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,236,0,25,[9,50,78,106,131,159,185,212,232,256,280,312,339,370,397,421,447,470,499,536,559,587,617,643,661],{"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":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100652914","detection-of-atrial-fibrillation-using-ppg-from-smartphone-cameras-100652914",false,"NCT07779213","Detection of Atrial Fibrillation Using PPG From Smartphone Cameras","Detection of Atrial Fibrillation Using Photoplethysmography From Smartphone Cameras","FLASH AF","Inclusion Criteria:\n\n1. Adults aged 22 years or older\n2. Owns a smartphone and knows how to operate and navigate different applications.\n3. Individuals able to read, understand, and sign the consent form.\n4. Cardiology patients consulting the cardiac outpatient clinic.\n5. History of persistent AF or other cardiac rhythm\n\nExclusion Criteria:\n\n1. Participants with cognitive impairments\n2. Individuals who cannot read, speak, and\u002For understand English\n3. Patients with implantable neurostimulators, cardiac implantable device in an atrial or ventricular paced rhythm documented on a 12-lead ECG during the initial study visit","ALL","22 Minutes",{"count":21,"type":22},554,"ESTIMATED","1 Day","OBSERVATIONAL","The protocol is designed to enroll patients from at least 3 diverse clinical sites with smartphones who are being evaluated for the presence or absence of atrial fibrillation (AF) using the Heart Rhythm Software algorithm running on their smartphones. Algorithm output will be compared to a gold standard of 12-lead ECG recorded with a simultaneous PPG measurement.",[27],"Atrial Fibrillation (AF)",[29,30,31,32,33,34,35,36],"wearables","smartphone based ppg","ppg","digital health","health equity","atrial fibrillation","healthtech","cardiac monitoring","RECRUITING","2026-08-19",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":41},"2026-06-30",{"date":45,"type":22},"2026-11",{"name":47,"class":48},"Happitech BV","INDUSTRY",5,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100652860","pulsed-field-ablation-for-atrial-fibrillation-using-the-varipulse-catheter-100652860","NCT07779369","Pulsed Field Ablation for Atrial Fibrillation Using the VARIPULSE™ Catheter","VARI-POWER","Inclusion Criteria:\n\n* ≥18 years of age\n* AF and eligible for index PVI according to current ESC guidelines\n\nExclusion Criteria:\n\n* Unwilling or unable to give written informed consent\n* Prior left atrial ablation\n* Other left atrial arrhythmias including atrial flutters\n* Prior left atrial surgery\n* Severe mitral valve regurgitation\n* Contraindication for gadolinium-based contrast agents\n* Contraindications for CMR (including metallic implants, cochlear implants, cardiac devices, neurostimulation systems, claustrophobia)\n* Renal insufficiency (eGFR \\\u003C 30 ml\u002Fmin)","18 Years",{"count":59,"type":22},40,"INTERVENTIONAL",[62],"NA","Rationale: Effectiveness of thermal ablation techniques for pulmonary vein isolation, to treat atrial fibrillation (AF), are hampered by frequent pulmonary vein reconnection and risks of collateral tissue injury. Pulsed field ablation (PFA) offers a non-thermal, tissue-specific alternative that may provide more durable isolation while also reducing procedural risks. While early data for the CE-marked VARIPULSE™ PFA system are promising, long-term lesion durability remains mostly unquantified. To obtain a definitive estimate of PFA effectiveness, a systematic invasive re-mapping approach is required. Advanced cardiac magnetic resonance (CMR) imaging can quantify atrial fibrosis after PVI across different ablation modalities, but it is unknown how well these imaging findings correspond with invasive electrical mapping. In the current study, CMR serves as a complementary modality to explore whether imaging-based tissue changes align with invasively confirmed long-term isolation.\n\nObjective: The primary objective is to evaluate the long-term durability of pulmonary vein isolation (PVI) using the VARIPULSE™ Pro PFA system, as defined by the rate of electrical reconnection during systematic invasive re-mapping at three months.\n\nStudy design: Prospective multicenter intervention study. Study population: Patients ≥ 18 years old, eligible for primary PVI according to ESC guidelines, without contraindications for gadolinium-based contrast-enhanced CMR imaging.\n\nIntervention: Patients will undergo PVI using PFA with the VARIPULSE™ catheter. After 3-4 months, a re-map procedure will be performed to assess lesion durability and to re-isolate any electrical reconnections.\n\nMain study parameters\u002Fendpoints: Primary outcome measure: Patient-level PV lesion durability. Secondary outcome measures: Percentage chronic isolation for each PV; Location of reconnection during re-map and lesion characteristics; Presence, location, size, volume and composition of acute (within 72 hours) and chronic (3 months) ablation lesions and collateral tissue damage on CMR (in the atrial wall and surrounding structure); Procedural fluoroscopy time and radiation dose; Percentage direct isolation for each pulmonary vein (PV); Acute PV reconnection for each PV; Percentage freedom from atrial achyarrhythmias at 12 months follow-up; Incidence of procedure related adverse events. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation involves standard PVI care with additional CMR imaging and an invasive re-map procedure. Early studies show that PFA with the VARIPULSE™ catheter is safe, and the extra imaging adds only minimal burden or risk. The re-map study carries the same risks as standard ablation. Overall, the study is expected to provide valuable insights that may further improve patient care and outcomes in atrial fibrillation.",[27],[66,67,68],"Atrial Fibrillation","Pulsed Field Ablation","LGE-CMR","NOT_YET_RECRUITING",{"date":40,"type":41},{"date":72,"type":22},"2026-09",{"date":74,"type":22},"2028-09",{"name":76,"class":77},"Radboud University Medical Center","OTHER",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":60,"phases":89,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100640738","low-intensity-focused-ultrasound-targeting-the-stellate-ganglion-for-regulating-autonomic-nerve-function-and-sleep-quality-in-perioperative-patients-with-cardiovascular-diseases-100640738","NCT07595068","Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases","Low-Intensity Focused Ultrasound Targeting the Stellate Ganglion for Regulating Autonomic Nerve Function and Sleep Quality in Perioperative Patients With Cardiovascular Diseases: A Multicenter, Double-Blind, Randomized Controlled Trial","US-REST","Inclusion Criteria:\n\n1. Diagnosed with cardiovascular disease (CVD) and scheduled to undergo cardiology-related surgical treatment\n2. Able to receive and tolerate the aforementioned cardiology-related surgical treatment\n3. Aged between 18 and 79 years (inclusive), with no restriction on gender\n4. Agree to accept random allocation of the treatment strategies\n5. With clear consciousness, no severe mental disorders or cognitive impairment; voluntarily sign the written informed consent form (ICF) and are willing to actively cooperate with the study treatment\n\nExclusion Criteria:\n\n1. Have used sedative-hypnotic drugs, antipsychotic drugs, opioid analgesics, antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), central nervous system (CNS) stimulant drugs, or any other medications that alter sleep architecture within the past 30 days\n2. Have a history of cervical infection, trauma, severe cervical deformity, or prior cervical surgery\n3. Unable to complete the daily study intervention as required by the trial protocol\n4. Are participating in another clinical trial, or have participated in other clinical trials with interventions that may interfere with the results of this study\n5. Have undergone major surgery or general anesthesia within the past 30 days\n6. Have a history of alcohol abuse\n7. Are female subjects who are pregnant or lactating, or plan to become pregnant during the study period\n8. Have severe cognitive impairment, severe psychiatric disorders, epilepsy, or other related neurological disorders\n9. Have concomitant malignant tumor or severe dysfunction of vital organs\n10. Have active systemic infection\n11. Have significant bleeding tendency, or renal failure undergoing regular hemodialysis\n12. Are deemed unsuitable for the trial by the investigator for any other reason -","79 Years",{"count":88,"type":22},200,[62],"The goal of this multicenter, double-blind, randomized controlled trial is to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) stellate ganglion modulation for improving autonomic function and sleep quality in perioperative cardiovascular disease patients.\n\nThe main questions it aims to answer are:\n\n1. Does LIFU improve heart rate variability and sleep characteristics from baseline at 3-7 days post-surgery compared to sham ultrasound?\n2. Does LIFU improve serological markers, vital signs, Pittsburgh Sleep Quality Index (PSQI), and reduce \\>30-second perioperative arrhythmias?\n3. What is the safety profile of LIFU in this population? 200 eligible patients will be randomized 1:1 to receive either active LIFU (2.0W, 1MHz, 50% duty cycle, 30min daily for 3-7 days) plus standard care, or identical sham ultrasound plus standard care. A four-party double-blind design (subjects, operators, assessors, analysts) will be implemented. The study will run from May 1, 2026 to April 1, 2027 at 6 centers in China.\n\nParticipants will:\n\n1. Complete pre-surgery screening and baseline assessments (PSQI, 12h ECG\u002Fsleep monitoring, residual blood sample collection)\n2. Receive daily assigned ultrasound intervention for 3-7 consecutive days post-surgery\n3. Undergo 72h continuous ECG monitoring post-surgery, and repeat assessments at 3-7 days\n4. Have all adverse events and arrhythmias recorded throughout the study\n5. May withdraw voluntarily at any time without affecting routine medical care",[27,92],"Cardiovascular Diseases",[94,92,95,96,97],"Low-Intensity Focused Ultrasound","Stellate Ganglion","Autonomic Nervous Function","Sleep Quality",{"date":40,"type":41},{"date":100,"type":41},"2026-05-20",{"date":102,"type":22},"2027-04-01",{"name":104,"class":77},"Renmin Hospital of Wuhan University",7,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":60,"phases":116,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100569830","pacing-of-left-bundle-branch-area-and-atroventricular-node-ablation-in-patients-with-symptomatic-atrial-fibrillation-100569830","NCT06699342","Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation","PALLIATE-AF","Inclusion:\n\nPatients who meet all of the following inclusion criteria 1)-6).\n\n1. Permanent atrial fibrillation\n2. Age ≥ 65 years\n3. Refractory or intolerant to antiarrhythmic drugs, rate control medications, or catheter ablation\n4. New York Heart Association (NYHA) functional class II- IV\n5. LVEF \\> 40% (within the past 3 months)\n6. Patients with at least one of the following:\n\n   1. HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting ≥12 hours and including treatment with intravenous (IV) diuretics at a healthcare facility) within 12 months\n   2. Elevated NT-proBNP (\\>900 pg\u002Fml) in the 30 days prior to enrollment\n\nExclusion:\n\nPatients who meet at least one of the following exclusion criteria 1)-11).\n\n1. Asymptomatic atrial fibrillation\n2. Life expectancy to \\\u003C 12 months.\n3. Primary moderate to severe valvular disease (except for functional mitral valve regurgitation or tricuspid valve regurgitation)\n4. Mechanical tricuspid valve replacement\n5. Severe chronic kidney disease (estimated Glomerular Filtration Rate ≤ 15 ml\u002F1,73 m2 or receiving renal replacement treatment including hemodialysis or peritoneal dialysis)\n6. Obstructive hypertrophic cardiomyopathy\n7. Infiltrative cardiomyopathy (amyloidosis, sarcoidosis, Fabry disease, others)\n8. Acute coronary syndrome or coronary revascularization (CABG or PCI) \\\u003C3 months\n9. Severe primary pulmonary disease such as cor pulmonale, irreversible lung disease requiring inhalers, oxygen supplementation\n10. Pacemaker\u002FICD\u002FCRT treatment ongoing, or current pacemaker indication\n11. Simultaneous participation in a different randomized clinical trial","65 Years",{"count":115,"type":22},50,[62],"This study aimed to compare the clinical outcomes of left bundle branch area pacing combined with atrioventricular node ablation and pharmacologic treatment optimized according to guidelines in patients with symptomatic atrial fibrillation refractory or intolerant to drug therapy or catheter ablation.",[27],[34,120,121],"left bundle branch area pacing","Atrioventricular node ablation",{"date":123,"type":41},"2026-08-20",{"date":125,"type":41},"2025-01-27",{"date":127,"type":22},"2027-12-31",{"name":129,"class":77},"Seoul National University Hospital",1,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":60,"phases":141,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100606428","phase-2-safety-in-adult-participants-with-atrial-fibrillation-who-are-treated-with-anticoagulation-100606428","NCT07175428","Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation","A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)","ROXI-ATLAS","Key Inclusion Criteria:\n\n1. Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol\n2. Meets one of the following:\n\n   1. CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥2 and Oral Anticoagulant (OAC) naïve or\n   2. CHA2DS2-VA score ≥3 or\n   3. CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol\n3. Must have an International Normalization Ratio (INR) \\\u003C2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)\n\nKey Exclusion Criteria:\n\n1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)\n2. Has known moderate-to-severe mitral stenosis\n3. Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion\u002Fexclusion, or planned ablation or LAA occlusion\u002Fexclusion as described in the protocol\n4. Had an ischemic stroke within 2 days prior to randomization\n5. Has estimated Glomerular Filtration Rate (eGFR) \\\u003C15 mL\u002Fmin\u002F1.73m\\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol\n6. Has a history of central nervous system bleeding within 30 days prior to randomization\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":140,"type":22},1200,[142],"PHASE2","This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation.\n\nThe aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking REGN7508 or REGN9933\n* How well do the study drugs reduce the risk of having a stroke\n* How much of REGN7508 or REGN9933 is in the blood at different times\n* Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)",[27],[146,147,148,149],"Bleeding","Stroke","Systemic embolism","Blood clots","2026-08-18",{"date":123,"type":41},{"date":153,"type":41},"2025-10-20",{"date":155,"type":22},"2027-04-21",{"name":157,"class":48},"Regeneron Pharmaceuticals",77,{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":165,"targetDuration":167,"studyType":24,"phases":4,"briefSummary":168,"conditions":169,"keywords":175,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":181,"leadSponsor":183,"locationsCount":4},"100635406","hummingbird-ice-study-100635406","NCT07552272","Hummingbird ICE Study","Inclusion Criteria:\n\n* 18 years of age\n* Willing to provide written, dated and signed, informed consent\n* Undergoing percutaneous cardiac intervention procedures in with VeriSight Pro is used\n\nExclusion Criteria:\n\n* Contraindicated for ICE catheter placement or considerations that make placement of VeriSight not technically feasible\n* Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease\n* Pregnancy",{"count":166,"type":22},1000,"2 Days","The goals of this observational study are to collect data and ultrasound images using the Philips VeriSight Pro intracardiac echocardiography (ICE) catheter to assess safety and effectiveness and to support development efforts of the VeriSight Pro imaging platform.",[170,27,171,172,173,174],"ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION","Valve Disease, Heart","Atrial Septal Defect","Patent Foramen Ovale","Tricuspid Valve Disease",[176,177],"Intracardiac Echocardiography (ICE)","VeriSight","2026-08-17",{"date":38,"type":41},{"date":72,"type":22},{"date":182,"type":22},"2031-09",{"name":184,"class":48},"Philips Clinical & Medical Affairs Global",{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":60,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":130},"100652724","augmented-reality-aided-remote-access-and-technical-support-for-complex-ablation-procedures-100652724","NCT07777042","Augmented Reality Aided Remote Access and Technical Support for Complex Ablation Procedures","Augmented Reality Aided Remote Access and tecHnical suppOrt for compLex ablatiOn Procedures","HOLO-Remote","Inclusion Criteria:\n\n* Patients age ≥ 18 years\n* Indication for 3D electroanatomical mapping-based catheter ablation for the treatment of AF\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Patient is unable or unwilling to provide informed consent\n* Patient is included in another randomised clinical trial\n* Inability to comply with the study procedures",{"count":194,"type":22},60,[62],"Prospective, randomized, controlled, single-center pilot study evaluating the feasibility and safety of augmented reality-based remote technical support using the Microsoft HoloLens and EnSite™ Connected Care compared with conventional on-site support during 3D electroanatomical mapping-guided electrophysiological procedures. The study also assesses the feasibility of an AI-based algorithm integrated into the Medinbox Link system for automated procedural report generation and detection of protocol deviations from standard clinical practice.",[27],[199,200,201,202,203],"Atrial fibrillation","Remote access and technical support","Augmented reality","3D electroanatomical mapping","Catheter ablation","2026-08-16",{"date":123,"type":41},{"date":207,"type":22},"2026-08",{"date":209,"type":22},"2028-02",{"name":211,"class":77},"University of Luebeck",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":130},"100651193","peripheral-blood-lipidomic-and-ceramide-profiles-in-atrial-fibrillation-100651193","NCT07757282","Peripheral Blood Lipidomic and Ceramide Profiles in Atrial Fibrillation","Association of Peripheral Blood Lipidomic and Ceramide Profiles With Atrial Fibrillation: A Prospective Multi-Cohort Observational Study","LIPID-AF","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Participants who are able to provide informed consent.\n* Participants diagnosed with atrial fibrillation based on Holter monitoring, or control participants with other cardiovascular diseases and no documented atrial fibrillation.\n* Participants with available peripheral blood samples for untargeted lipidomic profiling or targeted ceramide analysis.\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent.\n* Missing key clinical information.\n* Missing or poor-quality peripheral blood samples unsuitable for lipidomic or targeted ceramide analysis.\n* Participants considered unsuitable for this study by the investigators.",{"count":88,"type":22},"This prospective multi-cohort observational study evaluates the association between peripheral blood lipidomic and ceramide profiles and atrial fibrillation. The study hypothesis is that peripheral blood lipidomic features and ceramide-related profiles are associated with the presence of atrial fibrillation. Participants with atrial fibrillation and control participants with other cardiovascular diseases will be prospectively enrolled. Peripheral blood samples will be analyzed using untargeted lipidomic profiling in one cohort and targeted ceramide assays in another cohort.",[27],"2026-08-07",{"date":225,"type":41},"2026-08-11",{"date":227,"type":41},"2017-06-15",{"date":229,"type":22},"2027-02",{"name":231,"class":77},"First Affiliated Hospital Xi'an Jiaotong University",{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":239,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":60,"phases":242,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":130},"100650802","net-clinical-benefit-of-edoxaban-versus-apixaban-in-patients-with-atrial-fibrillation-and-coronary-artery-disease-100650802","NCT07753200","Net Clinical Benefit of Edoxaban Versus Apixaban in Patients With Atrial Fibrillation and Coronary Artery Disease","SMARTDECISION3","Inclusion Criteria:\n\n* Patients must be at least 19 years of age\n* Patients with AF requiring oral anticoagulation therapy (CHA2DS2-VaSc 2 or more)\n* Documented coronary artery disease, defined as at least one of the following: history of percutaneous coronary intervention (PCI), history of coronary artery bypass grafting (CABG), major epicardial coronary artery stenosis ≥50% on coronary computed tomography angiography (CCTA) or invasive coronary angiography\n* Patients who can understand risks, benefits and treatment alternatives and sign informed consent voluntarily.\n\nExclusion Criteria:\n\n* Known hypersensitivity or contraindications to study medications (apixaban or edoxaban)\n* Severe renal impairment (creatinine clearance \\\u003C15 mL\u002Fmin) or dialysis\n* Active major bleeding\n* Indication requiring alternative anticoagulation (e.g., mechanical valve surgery or moderate \u002F severe mitral stenosis)\n* Non-cardiac co-morbid conditions are present with life expectancy \\\u003C1 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n* Pregnant or lactating women","19 Years",{"count":241,"type":22},3000,[243],"PHASE4","Non-vitamin K antagonist oral anticoagulants(NOACs) are standard care for thromboembolism prevention in patients with Aterial Fibrillation(AF). However, evidence comparing edoxaban and apixaban remains limited in AF patients with coexisting coronary artery disease(CAD). This study aims to evaluate whether edoxaban-based therapy is non-interior to apixaban-based therapy with respect to Net Adverse Clinical Events(NACE) in AF patients with concomitant CAD.",[27,246],"Coronary Arterial Disease (CAD)","2026-08-06",{"date":249,"type":41},"2026-08-10",{"date":251,"type":41},"2026-07-20",{"date":253,"type":22},"2031-12-31",{"name":255,"class":77},"Samsung Medical Center",{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":60,"phases":264,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":130},"100614138","waiting-on-atrial-fibrillation-intervention-therapy-wait-study-100614138","NCT07275697","Waiting on Atrial Fibrillation Intervention Therapy (WAIT) Study","WAIT","Inclusion Criteria:\n\nTo be included in the trial, subjects must meet all of the following criteria:\n\n1. Provision of written informed consent prior to participation.\n2. Age ≥18 years.\n3. Scheduled for first-time catheter ablation for atrial fibrillation using a pulmonary vein isolation (PVI) technique.\n4. Body Mass Index (BMI) ≥30 kg\u002Fm² (obesity) OR\n\n   BMI ≥27 kg\u002Fm² (overweight) with one or more of the following comorbidities:\n   * prediabetes (defined as HbA1c 39-47 mmol\u002Fmol or fasting glucose 5,6-6,9 mmol\u002FL),\n   * known diabetes type 2\n   * known hypertension (prior diagnosis and\u002For treatment with antihypertensive medication)\n   * new diagnosis of hypertension (according to ESC GL for hypertension: Systolic BP ≥140 mmHg and\u002For diastolic BP ≥ 90 mmHg based on two readings on two separate visits, OR Ambulatory BP monitoring (24h average) ≥ 130\u002F80 mmHg)\n   * dyslipidemia defined as either one of the following\n\n     * Known diagnosis of hyperlipidemia or\n     * Treatment with lipid lowering medication\n\n   OR either of the following:\n   * LDL \\> 3.0 mmol\u002Fl\n   * Total cholesterol \\> 5 mmol\u002Fl\n   * Triglycerides \\> 1.7 mmol\u002Fl\n   * HDL (\\\u003C 1 mmol\u002Fl if male, \\\u003C 1.2 mmol\u002Fl if female) AND\u002FOR\n\n     * atherosclerotic cardiovascular disease (prior myocardial infarction (MI), stroke, or peripheral arterial disease with claudication and ankle-brachial index \\\u003C0.85, prior revascularization, or amputation)\n     * obstructive sleep apnea.\n5. For women of childbearing potential: Inclusion after a highly sensitive negative pregnancy test and agreement to use highly effective contraception during the study period (e.g., hormonal contraception, intrauterine device, or barrier method combined with spermicide).\n\nExclusion Criteria:\n\n* Morbid obesity (BMI \\>40 kg\u002Fm²).\n* Current use of GLP-1 receptor agonist therapy or dual agonist therapy within 6 months before screening.\n* Current use of DPP-IV inhibitors.\n* Diabetes type 1\n* Known intolerance or contraindication to semaglutide.\n* History of pancreatitis or recurrent hypoglycemia.\n* Uncontrolled diabetic retinopathy\n* Severe renal failure (estimated glomerular filtration rate \\[eGFR\\] \\\u003C15 mL\u002Fmin\u002F1.73 m² or in dialysis)\n* Severe hepatic failure (decompensated liver disease Child-Pugh class C)\n* Severe cardiac failure (NYHA class IV)\n* Life expectancy \\\u003C12 months.\n* Inability to self-administer the investigational medicinal product.\n* Prior catheter ablation procedure for atrial fibrillation.\n* Pregnancy, breastfeeding, or planned pregnancy during or within two months after the study period.\n* Participation in another interventional clinical trial within the past 30 days.",{"count":88,"type":22},[243],"Atrial fibrillation (AF) is the most common heart rhythm disorder and is associated with symptoms, reduced quality of life, heart failure, stroke, and a high risk of recurrence after catheter ablation. Many patients scheduled for their first ablation are overweight or have obesity, which is one of the strongest predictors of AF recurrence. Weight loss and risk-factor management are known to improve the outcome of ablation, but lifestyle changes are often difficult to achieve in routine care.\n\nSemaglutide (Wegovy®) is a GLP-1 receptor agonist approved in the EU for weight management. It has been shown to produce substantial and sustained weight loss and to improve metabolic and cardiovascular risk factors. Whether treatment with semaglutide before AF ablation can improve long-term rhythm outcomes has never been tested in a randomized clinical trial.\n\nThe WAIT-AF study is a randomized, open-label trial with blinded endpoint assessment. The study includes adults with AF who are scheduled for their first catheter ablation and have a BMI ≥30 kg\u002Fm², or ≥27 kg\u002Fm² with at least one additional cardiovascular risk factor (such as hypertension, diabetes and dyslipidemia). A total of 200 participants will be enrolled.\n\nParticipants are randomly assigned in a 1:1 ratio to either standard care or semaglutide (plus lifestyle advice) prior to their scheduled ablation. Semaglutide is administered according to the approved EU label with gradual dose escalation. All participants receive an implantable loop recorder (ILR) before ablation to continuously monitor heart rhythm throughout the study.\n\nThe primary objective is to determine whether semaglutide improves arrhythmia-free survival 12 months after AF ablation. Recurrence is defined as AF, atrial flutter, or atrial tachycardia lasting ≥30 seconds on continuous ILR monitoring, excluding the standard 3-month blanking period.\n\nSecondary outcomes include weight loss, changes in blood pressure, AF symptoms, quality of life, AF burden, need for repeat ablation, hospitalizations for cardiovascular causes, and changes in metabolic risk factors. The study also evaluates safety and tolerability of semaglutide in this patient population.\n\nThe study aims to determine whether targeted weight management with semaglutide before AF ablation can improve long-term rhythm outcomes and overall cardiovascular health. If successful, this strategy may offer a new approach to optimizing treatment and improving the results of catheter ablation for patients with AF and overweight or obesity",[27,267],"Obesity & Overweight",[269,270,271,272],"Semaglutide","Implantable Loop Recorder","Ablation","Pulmonary Vein Isolation",{"date":249,"type":41},{"date":275,"type":41},"2026-03-23",{"date":277,"type":22},"2028-12-30",{"name":279,"class":77},"Emma Svennberg",{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":60,"phases":290,"briefSummary":291,"conditions":292,"keywords":297,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":49},"100619784","option-emea-clinical-trial-100619784","NCT07349121","OPTION-EMEA Clinical Trial","Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]","OPTION-EMEA","Inclusion Criteria:\n\n1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.\n2. Subjects who are willing and able to provide informed consent.\n3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.\n4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Subjects who underwent prior AF ablation procedure.\n2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible \u002F non-cardiac causes.\n3. Already surgically closed or otherwise excluded LAA.\n4. The LAA anatomy does not accommodate a Closure Device.\n5. Known or suspected atrial myxoma.\n6. Presence of intracardiac thrombus\\*.\n7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) \u002F patent foramen ovale (PFO) device.\n8. Subjects with a presence of a mechanical valve prosthesis in any position.\n9. Subjects with a myocardial infarction within 90 days prior to enrollment.\n10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.\n11. Any planned electrical cardioversion within 30 days following LAAC device implant.\n12. Subjects with a known inability to obtain vascular access.\n13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present.\n14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina).\n15. Subjects with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation.\n16. Subjects who are pregnant or planning to be pregnant.\n17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.\n18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.",{"count":289,"type":22},500,[62],"The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case.\n\nThe study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.",[27,293,294,67,295,296],"Stroke Prevention in Patients With Atrial Fibrillation","Left Atrial Appendage Closure","Atrial Fibrillation Ablation Procedure","Concomitant Procedures",[298,299,300,301,302],"WATCHMAN","FARAPULSE","Concomitant","PFA","LAAC","2026-08-04",{"date":305,"type":41},"2026-08-05",{"date":307,"type":41},"2026-06-18",{"date":309,"type":22},"2029-12",{"name":311,"class":48},"Boston Scientific Corporation",{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":60,"phases":321,"briefSummary":322,"conditions":323,"keywords":324,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":338},"100650760","smartphone-based-ppg-assessment-of-reconversion-in-persistent-atrial-fibrillation-100650760","NCT07752940","Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation","Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation: a Randomized Controlled Trial","SPARE-AF","Inclusion Criteria:\n\n* Provide signed and dated informed consent\n* Males or females aged ≥ 18 years\n* Diagnosis of atrial fibrillation based on ECG in medical history\n* Patient in atrial fibrillation when planned for electrical cardioversion as evidenced by an ECG\n* In possession of a smartphone\n* Being able and having the time to perform heart rhythm measurement using the FibriCheck application at home\n\nExclusion Criteria:\n\n* Cardiac implantable devices such as pacemakers, CRT's or ICD's.\n* No access to a smartphone or unable to perform PPG measurements independently.\n* Active follow-up in Fibricheck care pathways",{"count":88,"type":22},[62],"This study investigates whether a smartphone application that measures heart rhythm using light, a technique known as photoplethysmography or PPG, can accurately detect when the cardiac arrhythmia atrial fibrillation (AF) spontaneously terminates and the heart returns to normal sinus rhythm. This is a prospective, multicentre randomised controlled study conducted at Hospital East Limburg and University Hospitals Leuven.\n\nContinuous heart rhythm monitoring with conventional equipment is often not feasible in the home setting because of the high cost and complexity of the equipment. Smartphone-based PPG monitoring offers a practical and affordable alternative. The study will include 200 adult patients with known AF who are scheduled for elective electrical cardioversion. Patient will be randomised to either standard of care (no remote monitoring) or smartphone-based PPG monitoring. During the seven days preceding the procedure, participants in the intervention group will perform PPG and ECG measurements at predefined times using their smartphone and a chest strap.\n\nThe primary objective is to determine whether this intermittent, app-guided monitoring can detect spontaneous conversion to normal sinus rhythm before the planned cardioversion, thereby preventing unnecessary hospital admissions. In addition, we will evaluate the relationship between symptoms and cardiac rhythm, adherence to and user experience with self-monitoring, and the predictive value of the measured parameters for recurrence of AF or atrial flutter during one year of follow-up.",[27],[325,326,327,328,329],"electrical cardioversion","photoplethysmography","Remote monitoring","persistent af","RCT","2026-08-03",{"date":223,"type":41},{"date":333,"type":22},"2026-08-01",{"date":335,"type":22},"2028-07",{"name":337,"class":77},"Ziekenhuis Oost-Limburg",2,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":347,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":60,"phases":350,"briefSummary":351,"conditions":352,"keywords":355,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":130},"100625596","catheter-ablation-vs-conservative-care-in-elderly-patients-with-atrial-fibrillation-100625596","NCT07424690","Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation","Assessment of the Effect of Catheter Ablation on Elderly Population With Atrial Fibrillation; a Randomized Controlled Study; The ACE-AF Study","ACE-AF","Inclusion Criteria:\n\n1. Age ≥78 years.\n2. ECG-documented atrial fibrillation.\n3. AF type: paroxysmal, persistent, or longstanding persistent AF.\n4. Suitable candidate for catheter ablation according to ESC guidelines.\n5. Charlson's comorbidity index ≤7.\n\nExclusion Criteria:\n\n1. Left atrial (LA) dimension \\>55 mm, based on echocardiography within the previous year.\n2. Acute coronary syndrome or coronary artery bypass surgery within the last 12 weeks.\n3. Severe valvular heart disease (per ESC definitions) or congenital heart disease.\n4. Prior surgical or catheter AF ablation procedure, or prior AV-node (atrioventricular nodal) ablation.\n5. Contraindication to oral anticoagulation.\n6. AF due to a reversible cause.\n7. Medical condition likely to limit survival to \\\u003C12 months.\n8. Unable or unwilling to provide informed consent.\n9. History of non-compliance with medical therapy.\n10. BMI \\\u003C18 or \\>37 kg\u002Fm².","78 Years",{"count":349,"type":22},282,[62],"ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure.\n\nThe study compares two established treatment strategies:\n\n1. Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and\n2. Optimized medical therapy without AF ablation (medications for rate and\u002For rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care).\n\nParticipants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time.\n\nThe study has two primary endpoints, tested with Holm-Bonferroni multiplicity control assessed over 24 months:\n\n1. a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and\n2. patient-reported health-related quality of life (HRQoL), measured by the RAND-36 \"General Health\" domain.\n\nACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.",[27,353,354],"Atrial Fibrillation Ablation","Elderly",[34,356,357,358,359,360,361,362],"catheter ablation","rhtyhm control","rate control","implantable loop recorder","elderly","Health-related quality of life","Randomized controlled study",{"date":305,"type":41},{"date":365,"type":22},"2026-09-15",{"date":367,"type":22},"2034-09-15",{"name":369,"class":77},"Karolinska University Hospital",{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":60,"phases":380,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":394,"locationsCount":396},"100385439","comparison-of-laa-closure-vs-oral-anticoagulation-in-patients-with-nvaf-and-status-post-intracranial-bleeding-100385439","NCT04298723","Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.","Randomized Comparison of Interventional Closure of the Left Atrial Appendage Using a LAA Closure Device Versus Oral Anticoagulation Therapy in Patients With Non-valvular Atrial Fibrillation and Status Post Intracranial Bleeding.","CLEARANCE","Inclusion Criteria:\n\n* Signed written informed consent\n* Documented atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent)\n* CHA2DS2VASc-Score ≥2\n* Status post intracranial bleeding \\>6 weeks\n* Favorable LAA anatomy\n* Subject eligible for a LAA occluder device\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Comorbidities other than AF requiring chronic (N)OAC therapy, e.g. mechanical heart valve prosthesis, hereditary thrombophilia requiring livelong OAC - recurrent thrombosis\n* Symptomatic carotid disease (if not treated)\n* Thrombus in the left atrium or left atrial appendage\n* Active infection or active endocarditis or other infections resulting in bacteremia\n* Functional Impairment (modified ranking scale ≥4 )\n* Severe liver failure (Child-Pugh class C or liver failure with coagulopathy)\n* Pregnancy or breastfeeding\n* Subject with participation in another interventional clinical trial during this study or within 30 days before entry into this trial.\n* Known terminating disease with life expectancy \\\u003C1 year (including those with end-stage heart failure)\n* Subjects, who are committed to an institution due to binding official or court order\n* Subjects with planned cardiac or non-cardiac surgery or intervention. (These subjects can be included 30 days after intervention \u002F surgery",{"count":379,"type":22},530,[62],"Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.",[383,27,384],"Intracranial Hemorrhages","Atrial Flutter",[386,387,66,388,389],"Intracranial Hemorrhage","Intracranial Bleeding","Anticoagulation","LAA Occlusion",{"date":247,"type":41},{"date":392,"type":41},"2020-06-16",{"date":309,"type":22},{"name":395,"class":77},"Jena University Hospital",39,{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":60,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":4},"100650243","ablation-with-transcatheter-edge-to-edge-repair-for-atrial-functional-mitral-regurgitation-and-atrial-fibrillation-100650243","NCT07744035","Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation","Ablation wiTh TRAnsCatheter Edge-to-edge Repair Versus ablaTION Alone for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION Study)","ATTRACTION","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Left ventricular ejection fraction ≥ 50%\n* Grading of MR: 3+ or 4+ (effective regurgitant orifice area≥30mm2, regurgitant volume ≥45ml)\n* Valve morphology: MR originating from the mid portion of the valve; mitral valve area\\> 4 cm2; Length of posterior leaflet ≥10 mm; Sufficient leaflet tissue for mechanical coaptation: coaptation depth\\\u003C 11 mm, coaptation length\\> 2 mm\n* Rate control in suspected AF-induced cardiomyopathy (heart rate \\\u003C80 bpm at rest and \\\u003C110 bpm during exercise)\n* Patients must be willing to comply with all follow-up requirements\n\nExclusion Criteria:\n\n* Life expectancy\\\u003C 1 year due to non-cardiac conditions\n* Primary mitral regurgitation: valve abnormalities including leaflet tethering from LV dysfunction, intrinsic leaflet pathology (prolapse, flail, calcification, severe thickening), mitral annular calcification (either severe or \\\u003Csevere but extending into the leaflets), and\u002For any mixed pathology\n* Active endocarditis of the mitral valve or rheumatic mitral valve disease\n* Hypotension (systolic pressure \\\u003C 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support\n* Severe tricuspid regurgitation; Physical evidence of right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction; Fixed pulmonary artery systolic pressure\\> 70 mmHg\n* Stroke\u002FTIA, TAVR, CRT\u002F CRT-D\u002F ICD, cardiac intervention or surgery within 30 days before randomization\n* Any prior MV surgery or transcatheter procedure\n* Need for any cardiac surgery (other than for MV disease)\n* Untreated clinically significant coronary artery disease\n* Echocardiographic evidence of intracardiac thrombus\n* Active infections requiring current antibiotic therapy\n* Patients who cannot tolerate anti-platelet\u002Fanticoagulation agents\u002Fcontrast media\n* Pregnancy\n* Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with medical therapy) and follow-up visits\n* Patient (or legal guardian) unable or unwilling to provide written informed consent before study enrollment",{"count":406,"type":22},384,[62],"This trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF). The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the combination of transcatheter edge-to-edge repair (TEER) and catheter ablation, compared with catheter ablation alone.",[410,27],"Atrial Functional Mitral Regurgitation",[412,203],"Transcatheter edge to edge repair","2026-08-02",{"date":303,"type":41},{"date":416,"type":22},"2026-09-01",{"date":418,"type":22},"2029-09-01",{"name":420,"class":77},"Mao Chen",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":429,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":445,"locationsCount":130},"100650554","a-photoplethysmography-based-machine-learning-algorithm-for-early-atrial-fibrillation-detection-a-prospective-validation-study-100650554","NCT07749183","A Photoplethysmography-Based Machine Learning Algorithm for Early Atrial Fibrillation Detection: A Prospective Validation Study","Prospective Validation of a Machine-Learning Algorithm Using Photoplethysmography Signals for Early Detection of Atrial Fibrillation During Remote Telemonitoring","HeartCore AF","Inclusion Criteria:\n\n* Adults ≥18 years with a diagnosis of heart failure (HFrEF, HFmrEF, or HFpEF)\n* 12-lead ECG performed to confirm cardiac rhythm classification (AF vs. non-AF)\n\nExclusion Criteria:\n\n* Missing a valid PPG recording",{"count":88,"type":22},"This is a prospective study validating a new machine-learning algorithm that detects atrial fibrillation (AF) from photoplethysmography (PPG) signals, developed for integration into the Seerlinq remote monitoring platform. This algorithm builds on the same core PPG signal-processing technology as Seerlinq's HeartCore device, a CE-certified (Class IIb, MDR) device that monitors left ventricular filling pressures in heart failure patients. The algorithm will be validated through internal cross-validation, external validation against an independent cohort with paired PPG-ECG recordings, and validation in a cohort of patients with paroxysmal atrial fibrillation and frequent sinus-AF transitions.",[27,432],"Heart Failure",[434,435,436,437,438,439],"Photoplethysmography","Machine learning","Remote telemonitoring","Wearable device","Digital biomarker","Arrhythmia detection","2026-07-31",{"date":247,"type":41},{"date":443,"type":41},"2025-10-01",{"date":45,"type":22},{"name":446,"class":77},"Seerlinq s. r. o.",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":466,"leadSponsor":468,"locationsCount":4},"100649601","association-of-lipoproteina-with-postoperative-atrial-fibrillation-100649601","NCT07737444","Association of Lipoprotein(a) With Postoperative Atrial Fibrillation","LPa and POAF","Inclusion Criteria:\n\n* Age ≥18 years\n* Scheduled for elective or urgent CABG, valve replacement, or combined CABG and valve replacement\n* Willing to wear the Skiin chest band for the duration of the study\n* Have a smartphone with an Operating System compatible with the\n* Skiin Connected Life App (Android 9+ or iOS 13+)\n\nExclusion Criteria:\n\n* Emergency indication for CABG, valve replacement, or combined CABG and valve replacement\n* Prior cardiac surgery\n* History of pre-operative persistent atrial fibrillation",{"count":455,"type":22},20,"About one in three patients who undergo open-heart surgery develop an irregular heart rhythm called postoperative atrial fibrillation (POAF). This condition increases the risk of stroke, prolongs hospital stays, and raises the chances of complications and death compared with patients who do not develop it. Because of these serious outcomes, researchers are working to identify which patients are most at risk.\n\nOne potential blood marker is lipoprotein(a), or Lp(a). Higher levels of Lp(a) have been linked to abnormal heart rhythms in previous studies. We want to determine whether patients with elevated Lp(a) are more likely to develop POAF after heart surgery and better understand the biological mechanisms behind this risk.\n\nIn this study, patients will be grouped based on whether they have high or low Lp(a) levels. All participants will wear a chest band monitor that continuously tracks heart rhythm for 3 months after surgery to detect POAF. During surgery, small tissue samples from the heart will also be collected. By examining these samples, we will assess whether patients with elevated Lp(a) show more scarring and inflammation which are two pathways known to cause abnormal heart rhythms.\n\nThe goal of this study is to determine whether elevated Lp(a) increases susceptibility to POAF. This could help identify patients who may benefit from preventive treatments and closer monitoring. By understanding how Lp(a) affects heart tissue, we also hope to uncover the mechanisms that contribute to abnormal rhythm and guide the development of future targeted therapies to treat POAF and other heart rhythms.",[458,27],"POAF",[34,460,461,462],"Lp(a)","Inflammation","Fibrosis","2026-07-30",{"date":330,"type":41},{"date":416,"type":22},{"date":467,"type":22},"2028-09-01",{"name":469,"class":77},"Anthony Tang",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":60,"phases":479,"briefSummary":480,"conditions":481,"keywords":483,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":4},"100647156","phase-4-comparing-two-heart-medicines-for-fast-irregular-heartbeat-atrial-fibrillation-100647156","NCT07706075","Comparing Two Heart Medicines for Fast, Irregular Heartbeat (Atrial Fibrillation)","Verapamil Versus Metoprolol for Rate Control in Hemodynamically Stable Atrial Fibrillation With Rapid Ventricular Response","Inclusion Criteria:\n\n* Adult patients aged 18 years and above presenting to the Emergency Department\n* Confirmed diagnosis of atrial fibrillation with rapid ventricular response (heart rate ≥110 bpm) on 12-lead ECG\n* Hemodynamically stable at the time of enrollment (systolic blood pressure ≥90 mmHg, no shock, no acute pulmonary edema)\n* Willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Hemodynamic instability, cardiogenic shock, or acute decompensated heart failure\n* Known pre-excitation syndrome (e.g., Wolff-Parkinson-White syndrome) on baseline ECG\n* Severe left ventricular systolic dysfunction (ejection fraction less than 30%) as determined by echocardiography\n* Known hypersensitivity or contraindication to verapamil or metoprolol\n* Patients already taking rate control agents (beta-blockers, calcium channel blockers, or digoxin) in the last 24 hours\n* Major bradycardia (heart rate less than 50 bpm) or AV block (second or third degree) on baseline ECG\n* Active bronchospasm or severe obstruction of pulmonary disease\n* Severe hepatic impairment (Child-Pugh Class C) or acute renal failure (eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m²)\n* Pregnancy or breastfeeding\n* Inability to give informed consent",{"count":478,"type":22},120,[243],"The goal of this clinical trial is to learn whether intravenous verapamil or intravenous metoprolol controls heart rate more effectively in adult patients who arrive at the emergency department with atrial fibrillation and a fast heart rate (rapid ventricular response), but who are otherwise medically stable. Atrial fibrillation with a rapid heart rate is a common emergency, and doctors currently choose between these two standard medicines based on personal preference rather than strong local evidence, since there is limited research on this comparison in Pakistani patients.\n\nThe main questions this study aims to answer are:\n\nDoes a higher proportion of patients reach a target heart rate of less than 110 beats per minute within 30 minutes with verapamil compared to metoprolol? Which medicine controls the heart rate faster, on average? Are there differences in side effects (such as low blood pressure, slow heart rate, or breathing problems) between the two medicines? Researchers will compare a group of patients receiving verapamil to a group receiving metoprolol to see if one medicine controls the heart rate faster and more safely than the other.\n\nParticipants will:\n\n1. Receive either verapamil or metoprolol through an IV, with the dose given according to standard protocols\n2. Have their heart rate, blood pressure, and oxygen levels monitored continuously for 30 minutes after the medicine is given\n3. Be observed for any side effects during this monitoring period Both medicines used in this study are already standard, guideline-recommended treatments for this condition, so participation will not change or delay the medical care patients would normally receive.",[27,482],"Atrial Fibrillation With Rapid Ventricular Response",[34,484,485,486,487,488,489,490,491],"Rapid ventricular Response","Rate Control","Verapamil","Metoprolol","Calcium Channel Blockers","Beta Blockers","Cardiac Arrythmia","Hemodynamically unstable",{"date":330,"type":41},{"date":494,"type":22},"2027-01-01",{"date":496,"type":22},"2027-08-01",{"name":498,"class":77},"Muhammad Ali Javed",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":60,"phases":508,"briefSummary":509,"conditions":510,"keywords":513,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":535},"100615889","conquer-af-protocol-for-redo-ablation-procedures-in-recurrent-paroxysmal-and-persistent-atrial-fibrillation-using-the-sphere-9-catheter-and-affera-ablation-system-conquer-af-100615889","NCT07298473","Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)","Conquer-AF","Inclusion Criteria:\n\n* 1\\. History of a single AF ablation procedure for PAF or PsAF within 3 years prior to enrollment 2. Documented evidence of symptomatic AF, AT or AFL recurrence at least 90 days after subject's de novo ablation procedure, as demonstrated by:\n\n  * A physicians' note indicating at least 1 symptomatic AF, AT, or AFL episode occurring within 12 months prior to the enrollment; and\n  * At least 1 electrocardiographically documented episode of AF, AT, or AFL within 12 months prior to enrollment 3. Adults who are ≥18 years of age on the day of enrollment 4. Willing and able to comply with all study requirements and provide informed consent\n\nExclusion Criteria:\n\n* 1\\. Continuous AF lasting for 12 months or longer 2. LA anteroposterior \\>55 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume \\>100 mL for PsAF subjects; OR LA anteroposterior \\>50 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume \\>95 mL for PAF subjects 3. Previous left atrial percutaneous interventions including left atrial appendage occlusion and septal closure devices 4. Planned left atrial appendage (LAA) closure procedure, cardiac transplantation or implant 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) for any time during the follow-up period 5. More than 1 previous AF ablation procedure 6. Any prior surgical ablation procedure 7. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure 8. Contraindication to or unwillingness to use systemic anticoagulation 9. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder 10. 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) 11. Presence of any pulmonary vein stents 12. Known pre-existing pulmonary vein stenosis 13. Pre-existing hemidiaphragmatic paralysis 14. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, or any prior atriotomy 15. Moderate to severe mitral valve or aortic stenosis 16. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR) 17. Any cardiac surgery, myocardial infarction, PCI\u002FPTCA or coronary artery stenting which occurred within the 3 months preceding the consent date 18. NYHA Class III or IV congestive heart failure 19. Documented left ventricular ejection fraction (LVEF) ≤40%, measured by acceptable cardiac testing (e.g., TTE) 20. Unstable angina 21. Severe lung disease, primary pulmonary hypertension, or any lung disease requiring supplemental oxygen 22. Rheumatic heart disease 23. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition 24. Presence of left atrial thrombus on imaging 25. Active systemic infection or sepsis 26. Hypertrophic cardiomyopathy 27. Amyloid heart disease 28. Diagnosed atrial myxoma 29. Known reversible causes of AF (e.g., uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, acute alcohol toxicity or other reversible or non-cardiac cause) 30. Any cerebral ischemic event (strokes or TIAs) which occurred within the preceding 6 months of the consent date through the date of study index redo ablation procedure 31. Carotid stenting or endarterectomy 32. Thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure 33. Body mass index \\> 40 kg\u002Fm2 34. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\\* 35. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed 36. Current or anticipated participation in any other clinical study of a drug, device or biologic during the duration of the study not pre-approved by Medtronic 37. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2, or any history of renal failure requiring dialysis or renal transplant 38. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation 39. Presence of an inferior vena cava (IVC) filter (e.g., Greenfield or similar) that would preclude safe transfemoral venous access, catheter passage, or sheath manipulation.\n\n  40\\. Known drug or alcohol dependency 41. Significant congenital anomaly or medical problem that would, in the opinion of the investigator, preclude enrollment, follow-up compliance, or the scientific integrity of the study\n\n  \\*Women who are of child-bearing potential must undergo a pregnancy test after consent and prior to the study index redo ablation procedure, as allowed according to local regulations",{"count":507,"type":22},400,[62],"Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia.\n\nSubjects diagnosed with symptomatic recurrent paroxysmal or persistent atrial fibrillation after a single prior ablation procedure will be enrolled in this study. Each subject will undergo a study index redo ablation procedure using the Sphere-9 Catheter and Affera Ablation System and will be followed for 12 months. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 2 years.",[27,511,512],"Persistent Atrial Fibrillation","Paroxysmal Atrial Fibrillation (PAF)",[514,515,516,517,518,519,66,520,511,521,522,523,524,525,526,527],"Sphere-9 Catheter","Affera Ablation System","Affera Mapping System","Pulsed Field Ablation (PFA)","Radiofrequency Ablation (RFA)","Dual-Energy Ablation","Paroxysmal Atrial Fibrillation","Redo Ablation","Repeat Ablation","Electrophysiology Mapping","3D Cardiac Mapping","Left Atrial Ablation","Redo AF Ablation","Repeat Ablation Procedures",{"date":440,"type":41},{"date":530,"type":41},"2026-04-08",{"date":532,"type":22},"2028-03-29",{"name":534,"class":48},"Medtronic Cardiac Ablation Solutions",30,{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":60,"phases":545,"briefSummary":546,"conditions":547,"keywords":548,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":555,"leadSponsor":557,"locationsCount":49},"100650315","redo-pulmonary-vein-isolation-with-versus-without-posterior-wall-ablation---the-redo-pifpaf-pfa-study-100650315","NCT07745543","Redo-Pulmonary Vein Isolation With Versus Without Posterior Wall Ablation - The REDO-PIFPAF-PFA Study","Redo-Pulmonary Vein Isolation Using Pulsed-Field Ablation With Versus Without Posterior Wall Ablation in Patients With Symptomatic Atrial Fibrillation: A Multi-Centre Randomized Clinical Trial: The REDO-PIFPAF-PFA Study","Inclusion Criteria:\n\n1. Documented recurrence of paroxysmal or persistent AF following single prior catheter ablation with PVI, confirmed by 12-lead ECG, Holter monitoring, or ICM within the last 2 years.\n2. Candidate for repeat catheter ablation according to current European Society of Cardiology (ESC) AF management guidelines.\n3. Continuous oral anticoagulation with a vitamin K antagonist or non-vitamin K oral anticoagulant (NOAC) for ≥ 4 weeks prior to the ablation, or transoesophageal echocardiography (TEE) and\u002For cardiac computed tomography (CT) within 48 hours before the procedure excluding LA thrombus.\n4. Age ≥ 18 years at the time of informed consent.\n5. Written informed consent obtained prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Previous LA surgery\n2. \\> 1 prior LA ablation\n3. LA ablation outside of the PVs in the first LA ablation\n4. LA diameter \\>60 mm in the parasternal long axis\n5. Patients in persistent AF lasting \\>3 years\n6. AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)\n7. Pre-existing PV stenosis or PV stent\n8. Pre-existing hemidiaphragmatic paralysis\n9. Contraindication to anticoagulation or radiocontrast materials\n10. Prior mitral valve surgery\n11. Severe mitral regurgitation or moderate\u002Fsevere mitral stenosis\n12. Myocardial infarction during the 3-month period preceding the consent date\n13. Ongoing triple antithrombotic\u002Fanticoagulation therapy\n14. Cardiac surgery during the 3-month interval preceding the informed consent date or scheduled cardiac surgery\u002Ftranscatheter aortic valve implantation procedure\n15. Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including a patent foramen ovale)\n16. New York Heart Association (NYHA) class III or IV congestive heart failure\n17. Left ventricular ejection fraction (LVEF) \\\u003C35%\n18. Hypertrophic cardiomyopathy or left septal wall thickness \\>1.5 cm\n19. Significant chronic kidney disease (eGFR \\\u003C30 ml\u002Fmin)\n20. Uncontrolled hyperthyroidism\n21. Cerebral ischemic event (stroke or TIA) during the 6-month interval preceding the informed consent date\n22. Ongoing systemic infections\n23. Cardiac amyloidosis\n24. Pregnancy (to exclude pregnancy a blood test (HCG) is performed in women \\\u003C 50 years before inclusion)\n25. Life expectancy less than one year per physician opinion\n26. Currently participating in any other clinical trial, which may confound the results of this trial.\n27. Unwilling or unable to comply fully with the study procedures and FU.",{"count":544,"type":22},270,[62],"The study will compare two ablation strategies in patients with paroxysmal or persistent atrial fibrillation undergoing repeat ablation using pulsed-field ablation: redo pulmonary vein isolation only versus redo pulmonary vein isolation with added posterior wall ablation.",[27],[549,550,551],"Pulmonary vein isolation","Pulsed field albation","posterior wall ablation","2026-07-29",{"date":303,"type":41},{"date":207,"type":22},{"date":556,"type":22},"2031-07",{"name":558,"class":77},"University Hospital, Basel, Switzerland",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":567,"enrollmentInfo":568,"targetDuration":4,"studyType":60,"phases":569,"briefSummary":571,"conditions":572,"keywords":576,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":130},"100649878","phase-2-caffeine-consumption-and-rate-control-in-permanent-atrial-fibrillation-the-cafib-trial-100649878","NCT07738523","Caffeine Consumption and Rate Control in Permanent Atrial FIBrillation: The CAFIB Trial","Caffeine Consumption and Rate Control in Permanent Atrial Fibrillation: The CAFIB Trial","CAFIB","Inclusion Criteria:\n\n* Age ≥18 years.\n* Permanent atrial fibrillation diagnosed for more than 3 months.\n* Stable rate-control status, defined as a resting heart rate \\\u003C110 bpm without changes in rate-control medication during the previous 2 months.\n* Habitual caffeine consumption (≥1 cup\u002Fday of caffeinated coffee).\n* Willingness to participate in the study, including acceptance of complete caffeine abstinence for up to two months if assigned to the abstinence arm.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years or \\>80 years.\n* Previous diagnosis of cognitive impairment or dementia.\n* Legal incapacity or inability to provide informed consent.\n* Inability to understand or complete quality-of-life questionnaires.\n* Presence of a cardiac implantable electronic device with pacing capability (pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device).\n* Previous successful atrioventricular node ablation.\n* Decompensated heart failure (New York Heart Association class III-IV) or hospitalization for heart failure within the previous 3 months.\n* Acute coronary syndrome within the previous 3 months.\n* Stroke within the previous 3 months.\n* Cardiac surgery within the previous 3 months.\n* Severe unrepaired valvular heart disease.","80 Years",{"count":115,"type":22},[142,570],"PHASE3","The CAFIB trial is a multicenter, randomized, open-label, crossover clinical trial designed to determine whether habitual caffeine consumption in coffe adversely affects rate control in patients with permanent atrial fibrillation (AF).\n\nThe rationale stems from the discrepancy between traditional clinical recommendations, which often advise patients with arrhythmias to avoid caffeine, and the growing body of evidence suggesting that moderate coffee consumption is not associated with an increased risk of AF and may even confer cardiovascular benefits. However, no randomized study has specifically investigated this issue in patients with permanent AF, a population in whom rate control remains the cornerstone of management.\n\nThe primary hypothesis is that continued moderate caffeine consumption is non-inferior to caffeine abstinence regarding 24-hour mean heart rate control.\n\nParticipants will be randomly assigned in a 1:1 ratio to one of two treatment sequences stratified according to baseline coffee intake (1 cup\u002Fday vs. \\>1 cup\u002Fday). Owing to the nature of the intervention, the study is open-label; nevertheless, Holter recordings will be analyzed by blinded investigators, and the statistical analysis will also be performed blinded to treatment allocation to minimize bias.\n\nEligible participants are adults with permanent AF diagnosed for more than three months, stable ventricular rate control (\\\u003C110 bpm at rest), unchanged rate-control medication for at least two months, and habitual coffee consumption of at least one caffeinated cup per day. Patients with advanced heart failure, recent major cardiovascular events, cognitive impairment, implanted cardiac pacing devices, or other conditions likely to interfere with study outcomes are excluded.\n\nThe intervention compares two dietary strategies: continuation of regular caffeinated coffee consumption (at least one cup daily) versus complete caffeine abstinence, while allowing decaffeinated coffee. Energy drinks are prohibited in both groups, and participants assigned to abstinence are advised to avoid compensatory caffeine intake from other sources. No washout period is planned between crossover phases because caffeine has a biological half-life of less than 24 hours. Adherence will be assessed using caffeine consumption diaries and structured interviews at each study visit.\n\nThe primary endpoint s the 24-hour mean heart rate measured by ambulatory Holter electrocardiography. Secondary endpoints include changes in mean HR from baseline, percentage of time with HR \\>110 bpm or \\\u003C50 bpm, ventricular ectopic burden, symptom severity assessed using the modified EHRA classification, quality of life evaluated with the AFEQT questionnaire, circulating biomarkers of heart failure, adverse events, and changes in concomitant medical therapy.\n\nPatients will undergo three scheduled visits (baseline, 30 days, and 60 days), each including clinical assessment, ECG, 24-hour Holter monitoring, blood sampling, and quality-of-life questionnaires.\n\nSample size calculation was based on detecting a clinically relevant difference of 5 bpm, assuming a standard deviation of 7 bpm, 80% statistical power, and a two-sided α of 0.05. After accounting for an anticipated 25% dropout rate and potential protocol deviations, a total of 50 patients (25 per treatment sequence) will be recruited. The primary analysis will follow the intention-to-treat principle, complemented by a per-protocol analysis. Statistical models will adjust for clinically relevant covariates, including age, sex, baseline heart rate, and concomitant rate-control therapy, while multivariable regression analyses will explore predictors of optimal heart rate control.\n\nThe protocol acknowledges several limitations, including its open-label design, reliance on self-reported caffeine intake to assess adherence, interindividual variability in caffeine metabolism, and limited external validity to stable, habitual coffee consumers with permanent AF. Despite these limitations, CAFIB represents the first randomized trial specifically evaluating the impact of caffeine consumption on ventricular rate control in permanent AF.",[27,573,574,575],"Permanent Atrial Fibrillation","Coffee Consumption","Caffeine Abuse",[199,577,578,579,573],"Coffee","Caffeine","Heart Rate",{"date":440,"type":41},{"date":582,"type":22},"2026-07-27",{"date":584,"type":22},"2028-03-30",{"name":586,"class":77},"Hospital Universitario Getafe",{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":593,"eligibilityCriteria":594,"healthyVolunteers":595,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":60,"phases":598,"briefSummary":599,"conditions":600,"keywords":601,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":4},"100650004","empowering-veterans-in-research-effectively-using-virtual-engagement-tools-100650004","NCT07741955","Empowering Veterans in Research Effectively Using Virtual Engagement Tools","EVERYVET (Empowering VEterans in Research effectivelY Using Virtual Engagement Tools): A Patient-Centered Study","EVERYVET","Inclusion Criteria (Aim 2):\n\n* Age 65 years or older\n* CHA2DS2-VASc Score of 3 or greater\n* Veteran receiving care within the VA Health Care System\n* Eligible to receive a mailed invitation through the parent VA Cooperative Studies cardiovascular trial recruitment process\n\nExclusion Criteria (Aim 2):\n\n* Any exclusion criterion applied by the parent VA Cooperative Studies cardiovascular trial\n* Documented preference to opt out of VA research mailings\n\nInclusion Criteria (Aim 1 Qualitative Interviews):\n\n* Age 18 years or older\n* Veteran receiving care at VAPAHCS\n* Recently invited (within 3 months) to participate in an existing cardiovascular clinical trial at VAPAHCS\n* Able to provide informed consent in English\n\nExclusion Criteria (Aim 1 Qualitative Interviews):\n\n* Cognitive impairment documented in the electronic health record\n* Inability to communicate in English at a level sufficient for qualitative interview participation\n\nInclusion Criteria (Aim 1 Beta-Testing and Aim 3):\n\n* Age 18 years or older\n* Veteran receiving care at VAPAHCS or a participating VA-CTC site\n* Able to view a brief video and complete a short survey in English\n\nExclusion Criteria (Aim 1 Beta-Testing and Aim 3):\n\n\\- Inability to communicate in English at a level sufficient for survey completion\n\nInclusion Criteria (Focus Groups):\n\n* VA study coordinator or trial investigator actively engaged in cardiovascular clinical trial recruitment at VAPAHCS or a VA-CTC site\n* Willing to participate in a 60-90 minute virtual focus group",true,{"count":597,"type":22},100000,[62],"Cardiovascular disease is the leading cause of death among Veterans. Clinical trials are essential for developing better treatments, but Veterans remain underrepresented in these studies due to barriers including limited health literacy, lack of awareness, and mistrust. Current outreach approaches rely on either in-person physician conversations, which are limited by workforce constraints, or mailed letter invitations, which often fail to engage Veterans with limited health literacy. This study tests whether AI-generated video avatars can improve Veteran engagement in cardiovascular clinical trials.",[27,92],[602,603,604,605,606,607,608],"Veterans","Clinical Trial Recruitment","Cardiovascular Disease","Artificial Intelligence","Patient Engagement","Health Literacy","Virtual Outreach","2026-07-28",{"date":330,"type":41},{"date":612,"type":22},"2026-07",{"date":614,"type":22},"2030-07",{"name":616,"class":77},"Stanford University",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":18,"minAge":113,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":60,"phases":627,"briefSummary":628,"conditions":629,"keywords":630,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":4},"100649817","phase-3-study-to-evaluate-the-efficacy-and-safety-of-abelacimab-in-high-risk-patients-with-atrial-fibrillation-who-have-been-deemed-unsuitable-for-oral-anticoagulation-100649817","NCT07739888","Study to Evaluate the effIcacy and Safety of Abelacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral Anticoagulation","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","LILAC-TIMI 76","Inclusion Criteria:\n\n* Patients are able to provide written informed consent to enter the extension part.\n* Patients must be on study treatment at the time of EoT visit in the core part.\n\nExclusion Criteria:\n\n* Patients meeting any exclusion criteria in the core part.\n* Patients who have a history or evidence of any clinically significant disorder, condition, or disease that in the investigator's opinion or Sponsor physician (if consulted), would put the participant at risk or interfere with the study participation\n* History of hypersensitivity to the study drug or its excipients, to drugs of similar chemical classes\n* Any medical or psychiatric condition which in the judgment of the Investigator either requires urgent medical intervention\u002Fhospitalization or may preclude patients from complying with study requirements for the duration of the study.\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply",{"count":626,"type":22},2500,[570],"This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in eligible patients who completed the double-blinded core part of CMAA868A2302 (ANT-010\u002FNCT05712200)",[27],[631,632,633,634,635,34],"abelacimab","randomized","placebo-controlled","double-blind","endpoint evaluation",{"date":440,"type":41},{"date":638,"type":22},"2027-12-30",{"date":640,"type":22},"2030-12-30",{"name":642,"class":48},"Novartis Pharmaceuticals",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":113,"enrollmentInfo":650,"targetDuration":4,"studyType":60,"phases":651,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":657,"leadSponsor":659,"locationsCount":130},"100649858","medical-large-language-model-assisted-diagnosis-and-treatment-in-primary-care-chronic-disease-management-100649858","NCT07740044","Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management","Verification and Application Study of Medical Large Language Model-Assisted Diagnosis and Treatment in Primary Care Chronic Disease Management: A Randomized Controlled Study","Inclusion Criteria:\n\n1. Work experience of 3 years or more;\n2. Able to complete the case assessment tasks required by the study;\n3. Have a practicing doctor qualification;\n4. Work at a township health center or community health service center;\n5. Voluntarily participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\nN\u002FA",{"count":455,"type":22},[62],"This study aims to explore the feasibility of using medical large language models to assist in chronic disease management. By setting up experimental and control group interventions and having experts blindly evaluate anonymized cases, it compares different management approaches in chronic disease care, verifying the scientific basis, effectiveness, and potential for broader use of medical large language models in supporting chronic disease management.",[654,27,432,147],"Coronary Artery Disease",{"date":440,"type":41},{"date":178,"type":22},{"date":658,"type":22},"2026-11-30",{"name":660,"class":77},"Jiangsu Taizhou People's Hospital",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":60,"phases":671,"briefSummary":672,"conditions":673,"keywords":674,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":681,"completionDateStruct":682,"leadSponsor":684,"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":670,"type":22},177,[142,570],"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.",[27,66],[199,675,676,677,678],"Persistant atrial fibrillation","Electrical Cardioversion","Dual-Shock","Sinus Rhythm","2026-07-25",{"date":609,"type":41},{"date":333,"type":22},{"date":683,"type":22},"2028-02-27",{"name":685,"class":77},"Martín Negreira Caamaño, MD, PhD"]