[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-stenosis":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,86,0,25,[9,44,68,109,142,172,204,227,251,279,305,329,351,377,397,430,462,494,523,548,575,596,618,641,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100637150","transcatheter-aortic-valve-implantation-without-on-site-cardiac-surgery-100637150",false,"NCT07604402","TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery","TRanscatheter Aortic-Valve Implantation Without On-site Cardiac Surgery Broadened Access","TRACS-PRIME","Inclusion criteria\n\n1. Severe aortic stenosis\n2. Indication to TAVI confirmed by the Heart Team\n\nAND one of the following enrichment criteria:\n\n1. Prohibitive operative risk\n2. High surgical risk as defined as STS score \\>8%\n3. Porcelain aorta or severely atherosclerotic aorta\n4. Frailty\u002FReduced physical performance\n5. Severe liver disease\u002Fcirrhosis\n6. Hostile chest and\u002For internal mammalian artery or other critical conduit(s) crossing midline and\u002For adhering to the posterior table of the sternum\n7. Severe pulmonary hypertension and\u002For severe right ventricular dysfunction\n8. Age ≥85 years\n9. Severe Chronic Obstructive Pulmonary Disease (COPD) The criteria listed above qualify the patient for eligibility in the study if present immediately after the heart team has indicated TAVI. However, this does not exclude patients without these criteria from entering the study if the heart team's evaluation still considers their risk\u002Fbenefit profile appropriate for inclusion in the protocol.\n\nExclusion criteria\n\n1. Unsuitable for transfemoral TAVI\n2. Emergent TAVI\n3. Non-cardiovascular comorbidity reducing life expectancy to \\\u003C1 year\n4. Any factor precluding 1-year follow-up\n5. Refusal of informed consent","ALL",{"count":20,"type":21},1612,"ESTIMATED","INTERVENTIONAL",[24],"NA","TRACS-PRIME is a prospective, randomized, multicenter clinical trial evaluating whether transcatheter aortic valve implantation (TAVI) can be performed safely and effectively in selected hospitals without on-site cardiac surgery, when appropriate patient selection, experienced operators, advanced imaging, and established transfer pathways are available. The study will include patients with severe symptomatic aortic stenosis who have an indication for TAVI confirmed by a multidisciplinary Heart Team. Eligible patients will be randomized to undergo TAVI either in a center without on-site cardiac surgery or in a center with on-site cardiac surgery. All procedures will be performed according to current standards of care by experienced TAVI operators. The main purpose of the study is to determine whether TAVI performed in centers without on-site cardiac surgery is not inferior to TAVI performed in centers with on-site cardiac surgery with respect to clinical outcomes at 1 year. The primary clinical outcome includes death from any cause, stroke, or hospitalization related to the procedure or the implanted valve. The study will also assess safety outcomes, including valve-related death and major procedural or technical complications. Participants will be followed after hospital discharge to assess clinical events, safety, and longer-term outcomes. An independent committee blinded to treatment allocation will review clinical events, and an independent Data Safety Monitoring Board will monitor patient safety during the trial.",[27],"Aortic Stenosis",[29,30],"TAVI","on-site cardiac surgery","RECRUITING","2026-08-19",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-05-25",{"date":39,"type":21},"2034-05-25",{"name":41,"class":42},"University Hospital of Ferrara","OTHER",11,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100608708","improved-outcomes-with-pre-procedure-shockwave-ivl-of-common-femoral-artery-access-site-prior-to-large-bore-access-and-pre-closure-100608708","NCT07205068","Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and Pre-Closure","Inclusion Criteria:\n\n1. \\>18 years of age\n2. Patient with a diagnosis of severe aortic stenosis undergoing TAVR\n3. Participants must be able to read and understand study procedures\n4. Willing to participate and sign an ICF\n5. Patients with \\> 90-degree arc of calcium at the large bore access site per CT documentation\n\nExclusion Criteria:\n\n1. Unable to understand study procedures\n2. Unwilling to give consent\n3. Patients with cognitive impairments that can affect their ability to give consent\n4. Unfavorable calcium distribution of femoral artery","18 Years",{"count":52,"type":21},100,[24],"The primary purpose of this study is to observe reduced access site complications in patients with heavily calcified common femoral arteries requiring Transcatheter Aortic Valve Replacement (TAVR)",[27],[27,57],"Transcatheter aortic valve replacement","2026-08-14",{"date":60,"type":35},"2026-08-17",{"date":62,"type":35},"2025-10-04",{"date":64,"type":21},"2028-10-04",{"name":66,"class":42},"University of Tennessee Graduate School of Medicine",1,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":18,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100650944","importance-of-point-of-care-ultrasound-for-early-detection-of-valvular-and-cardiac-diseases-improve-100650944","NCT07756398","Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)","IMPROVE","Inclusion Criteria:\n\nProvider (cluster) participants:\n\n* Physician or advanced practice provider (physician assistant or nurse practitioner) practicing in primary care or geriatrics at a participating institution who independently assesses patients\n* Patient panel comprising \\>50% adults aged 65 years or older\n* Sees patients in ambulatory clinic at least 1 day per week on average\n* Agrees to participate, to undergo randomization, and to permit inclusion of all eligible patients from the panel\n* Provides written informed consent\n\nPatient participants:\n\n* Adults aged 65 to 85 years, inclusive\n* Attending a scheduled outpatient visit at a participating geriatrics or primary care clinic\n* Willing and able to provide written informed consent and, if the AI-POCUS screen is positive, to return for a confirmatory echocardiogram\n\nExclusion Criteria:\n\nProvider (cluster) participants:\n\n* Serving in a locum tenens or other temporary capacity\n* Unwilling or unable to nominate an AI-POCUS champion from the clinic\n\nPatient participants:\n\n* Echocardiogram performed within the past 5 years\n* At least moderate aortic or mitral valve disease, or left ventricular ejection fraction 50% or less, documented on any prior echocardiogram\n* History of surgical or transcatheter intervention for aortic or mitral valve disease\n* Self-reported structural heart disease\n* Significant frailty burden or comorbidities limiting life expectancy to\n\n  1 year or less\n* Unable to provide informed consent","65 Years","85 Years",{"count":78,"type":21},1088,[24],"Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop. Detection currently depends on a clinician hearing a murmur and then ordering an echocardiogram, which is easily missed or delayed.\n\nThis study tests whether a brief, artificial intelligence (AI)-guided handheld heart ultrasound - point-of-care ultrasound, or POCUS - performed by trained clinic staff during a routine visit identifies these conditions earlier than usual care.\n\nPrimary care and geriatrics providers, rather than individual patients, are assigned by chance to one of two groups. Patients seen by providers in the AI-ultrasound group are offered a POCUS scan and a one-time blood test at their regular visit, and are referred for a confirmatory echocardiogram if the scan is abnormal. Patients seen by providers in the usual care group receive standard clinic care. Researchers will compare how often previously undiagnosed structural heart disease is newly identified in each group.",[82,27,83,84],"Valvular Heart Disease Patients","Mitral Regurgitation","Left Ventricular Diastolic Dysfunction",[86,87,88,89,90,91,92,93,94,95,96,97,98],"Point-of-care ultrasound","POCUS","Artificial Intelligence","AI-guided imaging","Echocardiography","Screening","Early detection","Heart Failure","Older Adults","Geriatrics","Primary Care","Cluster randomized Trial","Implementation Science","NOT_YET_RECRUITING","2026-08-12",{"date":60,"type":35},{"date":103,"type":21},"2026-08-01",{"date":105,"type":21},"2028-12-01",{"name":107,"class":42},"University of Texas Southwestern Medical Center",2,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":117,"targetDuration":119,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":67},"100625305","study-of-the-progression-of-chronic-cardiovascular-conditions-100625305","NCT07420907","Study of the Progression of Chronic Cardiovascular Conditions","A Non-interventional Observational Study of the Sustained Use of Prolaio Digital Health Devices to Monitor the Natural History of Chronic Cardiovascular Conditions in Ambulatory Patients","OCORO","Inclusion Criteria:\n\n* 18 years of age and older\n* Ability to understand study assessments and give informed consent to data collection\n* Ability to comply with the study protocol\n* Ability to understand and respond to instructions in English\n* Has diagnosis of qualifying Cardiovascular Disease(s), including but not limited to: HF, AS, HCM, HTN, DCM, etc. Additional CVD may be included at discretion of the investigators.\n* Resides in the United States\n\nExclusion Criteria:\n\n* Allergy to adhesive used in biosensor patch\n* Life-threatening disease process outside of area under study, such as actively treated cancer or being actively considered for organ pre-transplant (such as hepatic failure; end-stage renal disease).\n* Severe CVD defined by hospital admission for cardiac diagnosis within 30 days of enrollment or documentation of NYHA functional class IV\n* \\-- For participants who do not qualify due to this exclusion, and have not been hospitalized within 30 days of enrollment, they may reapply to enroll in the study\n* Self-reported weight of 400 pounds or greater",{"count":118,"type":21},5000,"5 Years","OBSERVATIONAL","This study will collect physiologic data in patients with cardiovascular conditions and observe the natural history of those conditions for research purposes.",[123,93,27,124,125,126,127,128,129,130,131,132],"Cardiovascular Disease (CVD)","Aortic Stenosis Disease","Hypertension","Hypertension (HTN)","Hypertrophic Cardiomyopathy Patients","Hypertrophic Cardiomyopathy Without Obstruction","Hypertrophic Cardiomyopathy, Obstructive","Dilated Cardiomyopathy (DCM)","Dilated Cardiomyopathy","Dilated Cardiomyopathy, Familial","2026-08-10",{"date":100,"type":35},{"date":136,"type":35},"2025-10-30",{"date":138,"type":21},"2030-10",{"name":140,"class":141},"Prolaio","INDUSTRY",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":152,"conditions":153,"keywords":158,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":67},"100589345","prospective-long-term-evaluation-of-the-sapien-3-ultra-resilia-valve-100589345","NCT06953206","Prospective, Long-term Evaluation of the SAPIEN 3 Ultra RESILIA Valve","SAPIEN Ultra RESILIA Durability EU Registry - The RESOUND-EU Registry","RESOUND-EU","Inclusion criteria:\n\n* Adult patients (≥18 years)\n* Patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve\n* Patient is willing to attend the follow-up visits up to 10 years at the center\n\nExclusion criteria:\n\n* Lack of written informed consent\n* Emergency procedure\n* Pregnancy at time of TAVI\n\nCritieria for long-term observation (1y-10y):\n\n* Technical success at exit from procedure room (VARC-3):\n\n  * Freedom from mortality\n  * Successful access, delivery of the device, and retrieval of the delivery system\n  * Correct positioning of a single prosthetic heart valve into the proper anatomical location\n  * Freedom from surgery or intervention related to the device (excluding permanent pacemaker or PTA and stenting without major bleeding) or to a major vascular or access related, or cardiac structural complication\n* Absence of the following severe procedural and in-hospital complications (VARC-3 definitions):\n\n  * All stroke\n  * Bleeding type 3-4\n  * Myocardial infarction\n  * Need for a second valve\n  * Valve embolization\n  * Coronary obstruction\n  * Annular rupture",{"count":151,"type":21},500,"Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.",[154,155,156,157],"Transcatheter Aortic Valve Replacement (TAVR)","Aortic-Stenosis","Aortic Insufficiency","Degenerative Valve Disease",[159,160,161,29,27],"TAVR","SAPIEN 3 Ultra RESILIA Valve","S3UR","2026-07-29",{"date":164,"type":35},"2026-07-30",{"date":166,"type":35},"2025-09-15",{"date":168,"type":21},"2037-09-30",{"name":170,"class":171},"Institut für Pharmakologie und Präventive Medizin","NETWORK",{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":183,"conditions":184,"keywords":186,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100649762","same-day-versus-standard-hospital-discharge-after-tavi-home-tavi-100649762","NCT07738575","Same-Day Versus Standard Hospital Discharge After TAVI (HOME-TAVI)","HOspitalized Versus saME Day Discharge Transcatheter Aortic Valve Implantation (TAVI) With Self-expanding Valves. A Randomized Clinical Trial: The HOME-TAVI Trial","HOME-TAVI","Inclusion Criteria:\n\n* Adults (≥18 years of age)\n* Severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI\n* Treatment with the Medtronic Evolut PRO+, Evolut FX, Evolut FX+, or subsequent iterations\n* Successful TAVI procedure according to VARC-3 technical success criteria\n* Clinical stability 6 hours after TAVI\n* Written informed consent obtained before study participation\n\nExclusion Criteria:\n\n* Inability to ambulate independently at baseline\n* Hemodynamic or clinical instability before TAVI\n* Urgent or emergent TAVI procedure\n* Non-transfemoral access\n* Inadequate social support for discharge home\n* Inability to understand or comply with post-discharge instructions\n* Baseline right bundle branch block or high-grade atrioventricular block\n* Baseline left ventricular ejection fraction \\\u003C20%\n* Severe chronic kidney disease (estimated glomerular filtration rate : eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or dialysis).\n* Type 2-4 bleeding within 6 hours after TAVI\n* New-onset left bundle branch block or high-grade atrioventricular block within 6 hours after TAVI, unless a permanent pacemaker has already been implanted\n* New-onset atrial fibrillation within 6 hours after TAVI\n* Persistent hemodynamic instability within 6 hours after TAVI",{"count":181,"type":21},764,[24],"Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe aortic stenosis across a broad range of surgical risk. Advances in device technology and procedural techniques have enabled minimalist approaches and shorter hospital stays. Preliminary observational studies suggest that same-day discharge after TAVI may be feasible and safe in carefully selected patients, but randomized evidence remains limited, particularly in patients treated with self-expanding valves. The HOME-TAVI trial is a prospective, multicenter, international, randomized controlled trial designed to evaluate whether a same-day discharge strategy is non-inferior to standard hospital discharge after successful transfemoral TAVI with the Medtronic Evolut PRO+\u002FFX\u002FFX+ system. Eligible patients who remain clinically stable 6 hours after the procedure will be randomized in a 1:1 ratio to same-day discharge or standard-of-care discharge.\n\nThe primary endpoint is a composite of all-cause mortality, type 2-4 bleeding, stroke, and hospital readmission within 30 days after TAVI. Secondary objectives include assessment of quality of life, patient-reported experience measures, healthcare resource utilization, and cost-effectiveness.",[185,27],"Aortic Stenosis, Severe",[187,29,159,188,189,190,191,192,193],"Transcatheter Aortic Valve Implantation (TAVI)","Same-Day Discharge","Early Discharge","Self-Expanding Valve","Evolut FX","Evolut FX+","Evolut PRO+","2026-07-27",{"date":196,"type":35},"2026-07-31",{"date":198,"type":21},"2026-09-01",{"date":200,"type":21},"2029-06-01",{"name":202,"class":42},"Hospital Clinic of Barcelona",3,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":67},"100649741","systematic-ambulatory-ecg-monitoring-following-tavi-100649741","NCT07739316","Systematic Ambulatory ECG Monitoring Following TAVI","Systematic Ambulatory ECG Monitoring Following TAVI: A Prospective Randomized Trial.","RECORDII","Inclusion Criteria:\n\n* Age \\>18 years\n* Successful TAVI procedure.\n* Hospitalization discharge ≤72 hrs following the TAVI procedure.\n* Presence of at least 1 ECG abnormality at hospital discharge (QRS ≥120 ms OR PR ≥200 ms)\n\nExclusion Criteria:\n\n* Pacemaker implantation (pre- TAVI or during hospitalization after the procedure).\n* TAVI valve-in-valve procedure\n* Any complication or logistic reason precluding hospital discharge ≤72 hrs following the TAVI procedure.\n* Impossibility to obtain signed informed consent.",{"count":213,"type":21},754,[24],"This multicenter, prospective, randomized superiority trial will evaluate whether systematic 14-day ambulatory ECG monitoring following hospital discharge after transcatheter aortic valve implantation (TAVI) reduces the risk of sudden death, symptomatic arrhythmic events, or stroke within 1 year compared with standard post-discharge care. Patients undergoing successful TAVI without permanent pacemaker implantation and presenting with at least one ECG conduction abnormality at hospital discharge will be randomized to receive either ambulatory ECG monitoring or standard follow-up. All participants will undergo routine clinical follow-up at 30 days and 1 year after TAVI.",[27,217],"Conduction Disturbances",[29,219],"Ambulatory Electrocardiographic Monitoring",{"date":196,"type":35},{"date":222,"type":21},"2026-08",{"date":224,"type":21},"2028-12",{"name":226,"class":42},"Institut universitaire de cardiologie et de pneumologie de Québec, University Laval",{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":236,"conditions":237,"keywords":238,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100592291","a-study-of-transcatheter-aortic-valve-replacement-case-selection-and-valve-sizing-using-the-abc-bicuspid-sizing-algorithm-100592291","NCT06991517","A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm","A Prospective Cohort Study of Bicuspid Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm for Sapien 3 Balloon Expandable Valve","Inclusion Criteria:\n\n* Have bicuspid aortic valve disease\n* Have severe aortic stenosis or mixed aortic stenosis and regurgitation requiring treatment\n* Have no other condition requiring surgical intervention\n* Have had a TAVR CT scan (retrospectively gated contrast enhanced acquisition) that is of diagnostic quality and includes multiphase reconstructions of the aortic root at the minimum available slice thickness (with at least three systolic and one diastolic phases)\n* Would be treated with a Sapien 3 valve if found to be anatomically suitable for TAVR\n* Have a suitable access route for TAVR with a Sapien 3 valve\n\nExclusion Criteria:\n\n* Are treated with TAVR using a device other than a Sapien 3 valve\n* Are unable to be treated with TAVR due to intercurrent illness, clinical instability, or death on waitlist after being accepted for TAVR\n* TAVR considered high risk and not feasible due to risk of coronary occlusion, risk of sino tubular junction (STJ) injury and severe LVOT calcification\n* Annular area less than 275 mm² or more than 750 mm²",{"count":235,"type":21},290,"The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the Sapien 3 valve. The main questions the study aims to answer are:\n\n1. Does the ABC Bicuspid Sizing Algorithm increase the technical success at exit from the procedure room?\n2. Does the ABC Bicuspid Sizing Algorithm increase the device success at 30 days after the procedure?\n\nParticipants already being evaluated for a TAVR as part of their regular medical care for bicuspid aortic stenosis will have their diagnostic images assessed using the ABC Bicuspid Sizing Algorithm to help determine their procedure type and valve size. They will have visits 30 days and annually till 5 years after their procedure.",[27],[239,240],"Bicuspid Aortic Stenosis","Transcatheter Aortic Valve Replacement","2026-07-20",{"date":243,"type":35},"2026-07-21",{"date":245,"type":35},"2025-05-13",{"date":247,"type":21},"2031-12",{"name":249,"class":141},"World Health Research Inc.",20,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100378235","the-early-valve-replacement-in-severe-asymptomatic-aortic-stenosis-study-100378235","NCT04204915","The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study","A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis","EASY-AS","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Patient has severe asymptomatic AS, in line with current international guidelines, defined as either:\n\n   1. Peak velocity ≥4m\u002Fs OR mean pressure gradient ≥40mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2\u002Fm2 body surface area OR\n   2. Peak velocity ≥4m\u002Fs OR mean pressure gradient ≥40mmHg WITH aortic valve area \\>1.0 - ≤1.2cm2 OR \\>0.6 - ≤0.7cm2\u002Fm2 body surface area AND high sex specific calcium score\\* OR\n   3. Peak Velocity ≥3.5m\u002Fs - 3.9m\u002Fs AND mean pressure gradient \\\u003C40 mmHg WITH aortic valve area ≤1.0cm2 OR ≤0.6cm2\u002Fm2 body surface area AND high sex specific calcium score\\* \\*Sex specific high calcium scores (Agatston units): \\>1200 females; \\>2000 males\n3. The responsible clinician feels that either ongoing surveillance or early AVR are appropriate.\n4. Regarded by the treating cardiologist to be suitable for AVR (surgical or TAVI) with an acceptable risk\n5. Willing to provide informed consent and be randomised to early AVR or expectant management\n6. An ability to understand one of the written languages that the study has provided written and visual materials in, or the availability of a translator to explain the study documentation\n\n   Exclusion Criteria:\n7. Symptoms related to AS\n8. Additional severe valvular heart disease\n9. Other cardiac surgery planned pre-randomisation (eg CABG)\n10. Left ventricular systolic dysfunction (LVEF \\\u003C50%)\n11. Pregnancy\n12. Co-morbid condition that, in the opinion of the treating cardiologist, limits life expectancy to \\\u003C2 years\n13. Patient has previously undergone AVR or TAVI with restenosis",{"count":260,"type":21},2104,[24],"Aortic stenosis (AS) affects approximately 5% of individuals \\>65 years old, with \\~3% of people \\>75 years having moderate to severe disease. The prevalence of AS is rising rapidly due to an ageing population and is projected to double in the next two decades. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms because the heart compensates for the AS. Ultimately, compensatory mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients with severe AS remain untreated, they have a dire prognosis. In this situation the only effective treatment is AVR, either surgically or using TAVI. Conversely, conventional teaching and clinical practice in cardiology has been that, in the absence of symptoms, the prognosis is usually excellent and, except in a few very specific circumstances, conservative management and regular review (expectant management) is recommended. This advice is reflected in current international guidelines but is based largely on historical precedent. There has never been a randomised controlled trial to address the relative benefits of early AVR versus expectant management in patients with severe asymptomatic AS. The relative benefits of a strategy of early AVR\u002FTAVI versus expectant management in patients with asymptomatic severe AS are unclear. There is clinical equipoise but it remains one of the few areas of cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The EASY-AS study will provide crucial data on the relative merits of these differing approaches to management, in terms of important patient orientated outcomes, conventional cardiovascular end-points and cost effectiveness.",[27],[265,266,267,268,269,270],"Asymptomatic aortic stenosis","Aortic valve replacement","Randomised controlled trial","Expectant management","Hospitalisation for heart failure","Cardiovascular death",{"date":243,"type":35},{"date":273,"type":35},"2020-03-10",{"date":275,"type":21},"2031-04-01",{"name":277,"class":42},"University of Leicester",110,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":287,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":108},"100629847","multicenter-study-for-the-validation-of-willem-ai-aortic-stenosis-early-diagnosis-with-ai-electrocardiogram-study-100629847","NCT07479992","Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study","Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram (Willem AoS-SEDAI) Study","AoS-SEDAI","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* All available 12-lead ECG with a 10 seconds minimum length on raw data digital format will be included\n* Available clinical data corresponding to each ECG to confirm patient demographics and Aortic Stenosis diagnosis\n* Available transthoracic echocardiogram (TTE) within +\u002F- 90 days of each ECG recording\n\nNo exclusion criteria are defined for this study.",true,{"count":118,"type":21},"AoS-SEDAI study is an observational, multicenter, retrospective and prospective clinical study.\n\nThis study aims to assess Willem Artificial Intelligence (AI) ability to distinguish between aortic stenosis (AS) and non-AS patients from 12-lead electrocardiogram (ECG) data.",[27],[292,293,294,295,296],"artificial intelligence","electrocardiogram","deep learning","cardiac disease","aortic stenosis","2026-07-17",{"date":241,"type":35},{"date":300,"type":35},"2026-04-28",{"date":302,"type":21},"2026-12",{"name":304,"class":141},"Idoven 1903 S.L.",{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":67},"100380534","avr-thrombosis-outcome-study-100380534","NCT04234841","Avr Thrombosis OutcoMe Study","Can Thrombosis and Fibrinolysis Markers in Patients Undergoing Aortic Valve Replacement Predict Outcome","ATOM","Inclusion Criteria:\n\n1. Male and female patients aged 18 years or over.\n2. Patients diagnosed with aortic valve disease, undergoing surgical or transcatheter AVR and free of exclusion criteria below.\n3. The patient is willing and able to understand the Patient Information Sheet and provide informed consent.\n4. The patient agrees to comply with the study protocol, including phlebotomy and imaging as required at pre-specified time points.\n\nExclusion Criteria:\n\n1. Inability to provide valid informed consent.\n2. Male and female patients aged \\\u003C 18 years of age.\n3. The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses.\n4. The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or active psychiatric disease that may result in non-compliance with visits or inability to obtain venous access.\n5. Alcohol consumption above recommended safe levels (i.e. more than 14 units per week owing to the potential effects of high alcohol levels on platelet reactivity).\n6. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study such as sepsis.\n7. Any major bleeding diathesis or blood dyscrasia (platelets \\\u003C 70 x 109\u002Fl, Hb \\\u003C 8 g\u002Fdl, INR \\> 1.4, APTT \\> x 2 UNL, leucocyte count \\\u003C 3.5 x 109\u002Fl, neutrophil count \\\u003C 1 x 109\u002Fl).\n8. Currently enrolled in an investigational device or drug trial.\n9. Active or disseminated malignancy at the time of recruitment.\n\n   Additionally, for those patients taking part in the additional 4D CT angiography substudy:\n10. Any contraindications to CT angiography: renal failure (Cr\\>250 μmol\u002FL or eGFR\\\u003C30 mL\u002Fmin) due to the additional risk of contrast medium nephrotoxicity; or allergy to iodine.\n11. Women of childbearing age who have not had a hysterectomy and\u002For who may be breastfeeding.",{"count":314,"type":21},750,"This study aims to utilise novel biomarkers assessing thrombosis and thrombolysis (through a blood test), to identify patients undergoing either surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) who are at risk of thrombosis, and relate this to clinical thrombotic and thromboembolic adverse events and subclinical valve thrombosis, and identify the timeframe of greatest risk for valve thrombosis.",[27],[29,318],"SAVR","2026-07-14",{"date":321,"type":35},"2026-07-15",{"date":323,"type":35},"2020-02-01",{"date":325,"type":21},"2028-01",{"name":327,"class":328},"East and North Hertfordshire NHS Trust","OTHER_GOV",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":339,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":347,"leadSponsor":349,"locationsCount":4},"100634405","phase-2-to-establish-whether-dapagliflozin-and-spironolactone-in-patients-with-severe-aortic-stenosis-undergoing-aortic-valve-replacement-result-in-better-left-ventricular-mass-regression-myocardial-health-and-patient-reported-outcomes-100634405","NCT07539259","To Establish Whether Dapagliflozin and Spironolactone in Patients With Severe Aortic Stenosis Undergoing Aortic Valve Replacement, Result in Better Left Ventricular Mass Regression, Myocardial Health and Patient Reported Outcomes","Regression in Left Ventricular Hypertrophy and Fibrosis in Aortic Stenosis - a Randomised Controlled Trial","RELIEF-AS","Inclusion Criteria:\n\n* Participants ≥ 18 years\n* Left Ventricular Ejection Fraction (LVEF) ≥40%.\n* Diagnosed with severe symptomatic aortic stenosis\\* by a cardiologist or cardiac surgeon.\n\n  o Severity of AS follows international guideline criteria \\[38\\], namely at least one out of: effective orifice area \\[EOA\\] \\\u003C1.0 cm2, indexed EOA of ≤0.6 cm2\u002Fm2, peak velocity ≥4.0 m\u002Fs or mean gradient \\>40 mmHg. \\* including severe low flow low gradient AS\n* Referred for surgical or transcatheter AVR (SAVR or TAVI).\n* Able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Current use or intolerance or hypersensitivity to MRAs or SGLT2-inhibitors.\n* Hyperkalaemia (K\\>4.5 mmol\u002FL)\n* Significant renal impairment (eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m²)\n* Severe hepatic insufficiency\n* Concomitant severe other valve lesion (severe MR, MS or AR)\n* Contraindications to MRAs including:\n\n  * Addison's disease.\n  * Acute porphyrias.\n  * Receiving potassium-sparing diuretics, potassium supplements or strong inhibitors of CYP 3A4 (for example. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone).\n* Contraindications to SGLT2-inhibitors including:\n\n  * Active urinary tract infections.\n  * At risk or with a history of diabetic ketoacidosis\n* Type 1 or Type 2 Diabetes on insulin.\n* Concomitant diagnosis affecting trial participation or life expectancy of less than two years as evaluated by the treating clinician.\n* Contraindications to MRI (e.g. non-conditional cardiac pacemaker, severe claustrophobia, inability to lie flat: participants who do not meet local safety rules for MRI). NB: Conditional pacemakers\u002FICDs, if implanted after the baseline scan, are not an exclusion, depending on local expertise.\n* Ongoing participation in another CTIMP interventional clinical trial (i.e. drug trial), will not be permitted. Participation in any other trial will need to be discussed with the trial investigators.\n* Significant comorbidities that would contraindicate participation, including uncontrolled hypertension, or recent myocardial infarction (within 3 months prior to screening).\n* Pregnancy or breastfeeding, or females of childbearing potential not using an effective method of contraception.\n* Any other medical or psychiatric condition that would interfere with participation or compliance with study procedures as determined by the Principal Investigator (PI).\n\n  * As evidenced by features of decompensated cirrhosis e.g. hepatic encephalopathy, ascites, jaundice or markedly deranged liver blood tests e.g. elevated bilirubin, serum albumin \\\u003C30 or deranged clotting",{"count":338,"type":21},445,[340],"PHASE2","This trial aims to improve the heart health of people with a narrowed aortic valve called aortic stenosis (AS) who then have aortic valve replacement (AVR) by assessing the change in the mass of the left ventricle.\n\nEven after an AVR in many patients the heart is still unable to pump as well and can lead to heart failure.\n\nThis study will assess if medication used in other causes of heart failure can help participants having an AVR recover better. Researchers will compare two drugs, dapagliflozin and spironolactone, that have been shown to help patients with heart failure who do not have AS, to see if taking one or both medicines together will help patients with AS.\n\nThere will be four treatment arms: dapagliflozin, spironolactone, dapagliflozin and spironolactone together, and standard of care. These will be taken as one tablet of each IMP per day for 12 months.\n\nParticipants will have approximately four follow up visits, dependent on the treatment arm - those in an arm with spironolactone will have an extra safety follow up visit.\n\nThese medicines might help patients after AVR by reducing heart muscle thickness and scarring.",[27],"2026-07-10",{"date":345,"type":35},"2026-07-13",{"date":302,"type":21},{"date":348,"type":21},"2030-02-28",{"name":350,"class":42},"University College, London",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":376},"100516711","post-market-clinical-follow-up-study-with-navitor-valve-100516711","NCT06008080","Post-Market Clinical Follow Up Study With Navitor Valve","VISTA Nova Study (Navitor Post-Market Clinical Follow Up Study)","VISTA Nova","Inclusion Criteria:\n\n* Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.\n* The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the IRB (Investigational Review Board)\u002FEC (Ethics Committee) of the respective clinical site.\n* The patient and the treating physician agree that the subject will return for all required post procedure follow up visits.\n\nExclusion Criteria:\n\n* Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU)\n* Life expectancy \\\u003C 12 months from the time of informed consent due to non-cardiac co-morbid conditions.\n* In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and\u002For follow-up visits or that could impact scientific integrity of the study.\n* Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.\n* Inability to tolerate antiplatelet\u002Fanticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.\n* Currently participating in an investigational drug or device study that may confound the results of this study\n* Anatomy that makes insertion and endovascular access to the aortic valve difficult and\u002For impossible","100 Years",{"count":361,"type":21},1000,"Evaluation of the safety and performance of the Navitor TAVI System in a Global Study",[27],[365,366,27,367],"NAVITOR","Transcatheter aortic valve implantation (TAVI)","Cardiovascular Disease","2026-07-09",{"date":343,"type":35},{"date":371,"type":35},"2023-09-29",{"date":373,"type":21},"2032-06",{"name":375,"class":141},"Abbott Medical Devices",50,{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":393,"leadSponsor":395,"locationsCount":4},"100646456","remote-monitoring-for-patients-with-aortic-stenosis-100646456","NCT07690748","Remote Monitoring for Patients With Aortic Stenosis","Remote Monitoring for Asymptomatic Patients With Moderate to Severe Aortic Valve Stenosis - Remote-AS","Remote-AS","Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Suitable to undergo MRI scans\n* With asymptomatic moderate to severe native AS (based on guideline-recommended diagnosis and care)\n* Eligible for Medicare\n* Ability and willingness to provide written and informed consent and to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Serious comorbidity other than AS that limits the life expectancy (\\\u003C2 years), or affects study participation or outcome (severe frailty and mobility issues \\[Rockwood frailty score \\>6\\], severe kidney disease eGFR\\\u003C30, infiltrative cardiomyopathy)\n* Known heart failure or reduced left ventricular ejection fraction (\\\u003C50%)\n* Moderate or above valvular pathology other than AS\n* Contra-indications to CMR (including presence of foreign metallic bodies)\n* Known hypersensitivity to adenosine (ever requiring hospital admission with asthma or chronic obstructive pulmonary disease) or gadolinium\n* Significant renal impairment (eGFR\\\u003C30ml\u002Fmin\u002Fm2)",{"count":386,"type":21},160,"Remote-AS aims to develop a remote digital monitoring cohort of people with AS and use these data to establish a digital twin intervention to personalise risks and benefits, and optimise the time of surgical or transcatheter aortic valve replacement (AVR) referral. Our digital solution will also seek modelling for optimal care for patients to whom AVR is indicated who choose not to undergo the procedure, supporting a patient-selected observational strategy for managing heart failure symptoms, facilitating patient education and self-care.\n\nObjectives of the study are:\n\n* To establish a large-scale interdisciplinary research program to drive implementation of substantial improvements to health care and\u002For health system effectiveness in patients with aortic stenosis (AS)\n* To establish a new model of patient-centred management strategy for asymptomatic severe AS to inform the optimal time at which valve intervention should take place\n* For patients to whom AVR is indicated who choose not to undergo the procedure, to support a patient-selected observational strategy for managing heart failure symptoms\n* To develop a digital twin with predictive capabilities of artificial intelligence (AI) for guiding the optimal timing of AVR in patients with asymptomatic severe AS\n\nParticipants will be patients with asymptomatic moderate to severe native AS (n=160) (based on guideline-recommended diagnosis and care with peak aortic velocity \\>3.5m\u002Fsec).\n\nParticipants will undergo:\n\nWearables: collection of physiological (e.g., blood pressure, heart rate, rhythm) and behavioural (physical activity) data through a wearable device ('smart watch'), collected through the comprehensive remote heart health monitoring and automated feedback delivery system app SMART.\n\nPatient reported outcome measures: KCCQ-CSS; EQ-5D-5L index score; \"Toronto Aortic Stenosis\" quality of life questionnaires.\n\nAdvanced cardiovascular imaging: Cardiovascular magnetic resonance (CMR) imaging; 31phosphorus magnetic resonance spectroscopy (31P-MRS); proton magnetic resonance spectroscopy (1H-MRS); echocardiography.\n\nComprehensive plasma proteome profiling: Plasma proteomic preparation coupled with the Orbitrap Astral mass spectrometer.\n\nRecording of clinical outcomes.",[27],"2026-07-06",{"date":391,"type":35},"2026-07-08",{"date":198,"type":21},{"date":394,"type":21},"2030-08",{"name":396,"class":42},"Baker Heart and Diabetes Institute",{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":406,"conditions":407,"keywords":413,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":203},"100504659","mechanisms-of-disease-progression-in-aortic-stenosis---the-modas-study-100504659","NCT05851209","Mechanisms Of Disease Progression in Aortic Stenosis - the MODAS Study","Evaluation of Immunologic and Image Morphologic Parameters to Predict Disease Progression in Patients With Moderate Aortic Valve Stenosis","Inclusion Criteria:\n\n* The patient has an acquired (tricuspid) moderate aortic valve stenosis, which is the reason for regular outpatient cardiological care.\n* The subject has been informed verbally and in writing about the study and has given written consent to participate in this study.\n* Age \\> 18 years\n\nExclusion Criteria:\n\n* The subject has contraindications for the performance of a magnetic resonance imaging or computed tomography (e.g., severe arrhythmias , contrast agent intolerance, a pacemaker, or severe renal insufficiency or severe renal insufficiency or claustrophobia).\n* Presence of only mild or already high-grade acquired tricuspid Aortic valve stenosis\n* Patient with bicuspid aortic valve\n* Inability to follow the instructions of study personnel\n* Lack of written informed consent",{"count":405,"type":21},938,"Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the development of hemodynamically relevant aortic valve stenosis in order to identify high-risk patients and to develop further therapeutic options.",[27,408,409,410,411,412],"Imaging","Pathogenesis","Disease Progression","Aortic Valve Calcification","Genetics",[414,415,416,417,418,419,420],"severe aortic stenosis","disease progression","pathogenesis of degenerative aortic stenosis","early detection","Cardiovascular magnet resonance","Transthoracal echocardiography","computertomography","2026-06-26",{"date":423,"type":35},"2026-06-30",{"date":425,"type":35},"2023-07-01",{"date":427,"type":21},"2031-07",{"name":429,"class":42},"Heinrich-Heine University, Duesseldorf",{"id":431,"slug":432,"hasResults":12,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":437,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":445,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":203},"100614216","capture-2-controlled-arterial-protection-to-ultimately-remove-embolic-material-100614216","NCT07276711","CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material","Controlled Arterial Protection to Ultimately Remove Embolic Material","Clinical Inclusion Criteria\n\n1. Age ≥ 22 years at the time of consent\n2. Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or non-native (valve-in-valve) aortic valve. Note: Due to Neurologist availability and importance of capturing the neurological assessments, procedures must be performed Monday-Thursday.\n3. Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram\n4. Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures\n5. Willing and able to comply with the protocol-specified procedures and assessments\n\nImaging Inclusion Criteria\n\n1. Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and prior to randomization to confirm adequate cardiac function.\n2. Subjects must undergo a computed tomography angiography (CTA) scan within 6 months (180 days) prior to the index procedure and prior to randomization to confirm anatomic compatibility with the study device and the control device. Subjects must meet the following anatomical inclusion criteria:\n\nEmStop Angiographic (CTA) Inclusion Criteria 1. Subject anatomy is compatible with correct device positioning with:\n\n* Ascending aorta length ≥8 cm\n* Femoral and iliac artery minimal lumen diameter of ≥ 8.0 mm\n* Ascending aorta\u002Faortic arch diameter is ≥25 or ≤40 mm.\n* Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification\n\nSentinel Angiographic (CTA) Inclusion Criteria\n\n1\\. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with:\n\n* Artery diameter is 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery\n* Arterial stenosis \\\u003C70% in either the left common carotid artery or the brachiocephalic artery\n* Brachiocephalic or left carotid artery without significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium\n* Adequate blood flow to the right upper extremity\n* Access vessels without excessive tortuosity\n\nExclusion Criteria:\n\n1. Requires use of a balloon-expandable transcatheter aortic valve for the index procedure\n2. Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or deficit (National Institute of Health Stroke Scale \\[NIHSS\\] \\>1 at baseline)\n3. Left ventricular ejection fraction \\\u003C30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure\n4. Acute myocardial infarction (MI) within 30 days of the planned index procedure\n5. Planned to undergo any other open cardiac surgical or left heart interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a postoperative pacemaker implant after TAVR is not exclusionary.\n6. Renal failure, defined as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n7. Hypercoagulable state that cannot be corrected by additional periprocedural heparin\n8. History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated\n9. Undergoing therapeutic thrombolysis\n10. History of bleeding diathesis or major coagulopathy\n11. Hepatic failure (Child-Pugh class C)\n12. Active endocarditis or ongoing systemic infection, defined as fever (\\>38°C) and\u002For WBC \\>15,000 IU\n13. Known allergy to any materials used in the EmStop system (e.g., nitinol)\n14. Currently participating in another drug or device clinical study\n15. Known or suspected to be pregnant, or is lactating; women of child bearing age must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure\n16. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)\n17. Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study","22 Years",{"count":439,"type":21},663,[24],"The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus\u002Fdebris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.",[443,27,444],"Aortic Valve Stenosis","Aortic Valve Disease",[446,447,448,449,450,451,452,453],"Transcatheter aortic valve replacement (TAVR)","Cerebral embolic protection device","Stroke","Cerebrovascular accident","Neuroprotection","Aortic valve disease","Aortic valve stenosis","Aortic stenosis","2026-06-24",{"date":421,"type":35},{"date":457,"type":35},"2026-05-12",{"date":459,"type":21},"2028-05",{"name":461,"class":141},"EmStop Inc",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":469,"maxAge":470,"enrollmentInfo":471,"targetDuration":4,"studyType":22,"phases":473,"briefSummary":474,"conditions":475,"keywords":476,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":493},"100488920","phase-2-a-multicenter-trial-assessing-the-impact-of-lipoproteina-lowering-with-pelacarsen-tqj230-on-the-progression-of-calcific-aortic-valve-stenosis-100488920","NCT05646381","A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis","A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis [Lp(a)FRONTIERS CAVS]","Inclusion Criteria:\n\n* Male and female ≥50 to \\\u003C80 years of age at Screening Part II\n* Lp(a) ≥175 nmol\u002FL at the screening visit, measured at the Central laboratory\n* Mild or moderate calcific aortic valve stenosis\n* At the randomization visit, participant must be optimally treated for existing CV risk factors\n\nExclusion Criteria:\n\n* Severe calcific aortic valve stenosis\n* Uncontrolled hypertension\n* History of malignancy of any organ system\n* History of hemorrhagic stroke or other major bleeding\n* Platelet count ≤ LLN\n* Active liver disease or hepatic dysfunction\n* Significant kidney disease\n* Pregnant or nursing women\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","50 Years","80 Years",{"count":472,"type":21},502,[340],"The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.",[27],[477,478,479,480,481,482,483,452,453],"Cardiovascular","Lipoprotein(a)","Lp(a)","Hyperlipoproteinemia(a)","Calcific aortic valve stenosis","TQJ230","Pelacarsen","2026-06-19",{"date":486,"type":35},"2026-06-23",{"date":488,"type":35},"2024-03-07",{"date":490,"type":21},"2030-03-12",{"name":492,"class":141},"Novartis Pharmaceuticals",140,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":501,"targetDuration":503,"studyType":120,"phases":4,"briefSummary":504,"conditions":505,"keywords":509,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":522},"100638082","derivation-and-validation-of-the-aortic-valve-echocardiographic-calcium-score-to-confirm-severe-aortic-stenosis-the-echo-avcs-study-100638082","NCT07620925","Derivation and Validation of the Aortic Valve Echocardiographic Calcium Score to Confirm Severe Aortic Stenosis: the Echo-AVCS Study","Echo-AVCS","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Clinical indication for standard transthoracic echocardiography.\n* Clinical indication for cardiac CT with available calcium score.\n* 3-month time interval between transthoracic echocardiography and cardiac CT.\n* Able to give informed consent.\n\nExclusion Criteria:\n\n* Patients with inadequate transthoracic echocardiographic images.\n* Poor quality cardiac CT, inadequate for standard calcium score assessment.\n* Patients with known prior stents and\u002For coronary artery bypass grafts.\n* Patients with known previous percutaneous or surgical aortic valve replacement.\n* Patients with active or a history of endocarditis.\n* Patients with congenital heart defects (other than isolated bicuspid aortic valve).",{"count":502,"type":21},250,"1 Year","The Echo-AVCS Study is an investigator-initiated, prospective, multicenter observational study designed to derive and validate an artificial intelligence (AI)-based echocardiographic aortic valve calcium score (Echo-AVCS) for confirming severe aortic stenosis (AS). Transthoracic echocardiography (TTE) is the standard imaging modality for assessing AS severity; however, discrepancies between valve area and transvalvular gradient measurements may complicate diagnosis, particularly in low-flow or discordant AS presentations. Cardiac computed tomography (CT)-derived aortic valve calcium scoring is currently used to resolve diagnostic uncertainty, but it involves additional cost and radiation exposure. This study will enroll consecutive adult patients undergoing clinically indicated TTE and cardiac CT with calcium scoring performed within 3 months. Standardized echocardiographic images will be centrally analyzed using dedicated AI-based image segmentation and machine learning methods to quantify aortic valve calcification directly from TTE images. CT-derived aortic valve calcium score will serve as the reference standard. The primary objective is to derive and validate the Echo-AVCS score for identifying severe AS. Secondary objectives include determination of sex-specific diagnostic thresholds, correlation with CT calcium volume, association with symptoms and NYHA class, and evaluation of prognostic associations with aortic valve replacement, heart failure hospitalization, cardiovascular events, and mortality at 1-year follow-up.",[27,506,507,508],"Chronic Coronary Syndrome","Calcific Aortic Valve Disease","Calcific Aortic Stenosis",[453,510,511,90,512],"Low-flow","Aortic valve calcium score","Cardiac-CT","2026-06-03",{"date":515,"type":35},"2026-06-04",{"date":517,"type":35},"2026-03-01",{"date":519,"type":21},"2027-12-31",{"name":521,"class":42},"Azienda Ospedaliera \"Sant'Andrea\"",5,{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":544,"leadSponsor":546,"locationsCount":108},"100578954","phase-4-application-of-tavi-at-experienced-interventional-cardiac-centers-without-on-site-cardiac-surgery-atlas-study-100578954","NCT06818006","Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery (ATLAS Study)","Application of TAVI at Experienced Interventional Cardiac Centers Without On-site Cardiac Surgery","ATLAS","Inclusion Criteria:\n\n* Severe symptomatic AS reviewed and accepted for Transfemoral (TF) TAVI by an established Heart Team\n* Obtained informed consent\n\nExclusion Criteria:\n\n* Ambiguous aortic annular sizing on CT measurement deemed to increase the risk of valve embolization\n* Hostile aortic root on CT for TAVI implantation defined by, but not limited to:\n* High risk LVOT with a dimension significantly smaller than the annulus and\u002For extensive calcification\n* Features that increase the risk of coronary artery occlusion including inadequate coronary artery height and\u002For shallow coronary sinuses in the setting of a significant coronary artery territory at risk (accounting for prior CABG)\n* High risk STJ anatomy defined by inadequate height and\u002For diameter and\u002For excessive calcification\n* Vascular anatomy with increased risk of ascending aorta trauma (i.e. combinations of existing ascending aortic aneurysm, and\u002For unfolded aorta and\u002For extensive tortuosity and\u002For excessive iliofemoral calcification)\n* GFR \\\u003C15, excluding patients on dialysis\n* Life expectancy less than 3 years\n* Any factor precluding 1-year follow-up",{"count":532,"type":21},600,[534],"PHASE4","The purpose of this study is to see if having the Transcatheter Aortic Valve Replacement (TAVR) procedure done in a hospital with onsite cardiac surgery available or not, makes a difference on participant outcomes. Current standard of care is to have this procedure done in a hospital with onsite cardiac surgery available.\n\nHypothesis\n\nThe investigators hypothesize that the TAVR in experienced interventional cardiac centers without on-site cardiac surgery will be safe and effective. Although this is happening clinically in select regions internationally, this change in the clinical application of TAVI requires a rigorous assessment of safety with a robust randomized trial and multicenter international collaboration.",[27,537],"Severe Aortic Stenosis",[27,159,29,539],"Sever aortic stenosis","2026-06-01",{"date":542,"type":35},"2026-06-02",{"date":103,"type":21},{"date":545,"type":21},"2030-12",{"name":547,"class":42},"University of Alberta",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":558,"conditions":559,"keywords":561,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":4},"100640284","evaluation-of-a-management-algorithm-for-tavi-patients-with-concomitant-mitral-or-tricuspid-regurgitation-100640284","NCT07623083","Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation","Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation","MASTER-TAVI II","Inclusion Criteria:\n\n* Age \\>18 years.\n* Patients with severe AS undergoing transarterial TAVI.\n* Concomitant significant MR and\u002For TR (≥3+).\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year due to noncardiac conditions.\n* Any prior mitral or tricuspid valve surgery.\n* Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n* Active endocarditis.\n* Subjects in whom transesophageal echocardiography is contraindicated or high risk.",{"count":557,"type":21},300,"Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.\n\nMany patients undergoing TAVI also have leakage of the mitral valve and\u002For tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.\n\nIn some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.\n\nThis study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and\u002For tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.\n\nThe study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and\u002For tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.\n\nThe main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.\n\nThe results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.",[27,83,560,187],"Tricuspid Regurgitation",[453,366,562,563,564,565,566],"Multivalvular heart disease","Mitral regurgitation","Tricuspid regurgitation","Structural heart disease","Valve disease management algorithm","2026-05-28",{"date":513,"type":35},{"date":570,"type":21},"2026-06-05",{"date":572,"type":21},"2034-06-05",{"name":574,"class":42},"Josep Rodes-Cabau",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":582,"enrollmentInfo":583,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":595},"100575829","redo-transcatheter-aortic-valve-replacement-for-transcatheter-aortic-valve-failure-100575829","NCT06777368","REdo tranScatheter Aortic Valve Replacement for Transcatheter aOrtic Valve failuRE","RESTORE","Inclusion Criteria:\n\n* BVF of a TAV (either Medtronic or Edwards) requiring redo TAVR\n\nExclusion Criteria:\n\n* BVF due solely to paravalvular regurgitation\n* Active endocarditis\n* Untreated acute valve thrombosis\n* Life-expectancy less than 1-year\n* Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\n* Participating in another study that may influence the outcome of this study","105 Years",{"count":584,"type":21},225,"The purpose of this study is to generate clinical evidence on valve safety and performance in subjects treated by redo Transcatheter Aortic Valve Replacement (TAVR).",[27],"2026-05-27",{"date":567,"type":35},{"date":590,"type":35},"2025-02-06",{"date":592,"type":21},"2027-11",{"name":594,"class":141},"Medtronic Cardiovascular",71,{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":603,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":108},"100570949","identifying-biological-markers-of-cardiovascular-events-in-patients-with-aortic-stenosis-or-tavi-100570949","NCT06713889","Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI","Bio-TAVI","Inclusion Criteria:\n\n* Patients \\>=18 years of age\n* Patient with symptomatic or asymptomatic severe or moderately severe aortic stenosis (according to the recommendations of the European Society of Cardiology - ESC).\n* No opposition.\n\nExclusion Criteria:\n\n* Conjunctive heart disease (e.g. amyloidosis).\n* Presence of a contraindication to TAVI.\n* Impossibility of giving the subject informed information.\n* Privation of civil rights (curatorship, tutorship, protection of justice).",{"count":604,"type":21},125,"Aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion. These elements may precede the onset of symptoms. The assessment of inflammatory and fibrosis factors (in particular by means of biomarkers) in patients with aortic stenosis will make it possible to identify asymptomatic patients at greater risk who could benefit from intervention earlier. This is part of a personalised medicine adapted to the patient.\n\nPatients will be recruited during their TAVI (Transcatheter Aortic Valve Implantation) assessment consultation. If the patient agrees to take part in the study, information relating to routine care procedures will be collected (patient history, clinical examinations, electrocardiogram, echography, coronary angiography, TAVI procedure if applicable, biology).\n\nOutside of routine care, a biocollection will be established (serum, plasma), quality of life questionnaires will be carried out and adverse events will be collected where present.\n\nPatients will be divided into 3 groups according to the indication for TAVI (Group A - symptomatic severe aortic stenosis with indication for TAVI, Group B - asymptomatic severe aortic stenosis without indication for TAVI, Group C - asymptomatic moderate aortic stenosis without indication for TAVI).\n\nThe main objective is to compare the levels of biomarkers of inflammation and fibrosis between the 3 groups at each sampling time common to all three groups between inclusion and 1-year follow-up.",[27],[453,29,608,609],"Cardiology","Biomarkers","2026-05-22",{"date":587,"type":35},{"date":613,"type":35},"2024-12-19",{"date":615,"type":21},"2030-06",{"name":617,"class":42},"Hospices Civils de Lyon",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":22,"phases":628,"briefSummary":629,"conditions":630,"keywords":631,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":636,"completionDateStruct":637,"leadSponsor":639,"locationsCount":108},"100637068","cerebral-microembolization-during-transcatheter-aortic-valve-implantation-comparing-balloon-expandable-and-self-expanding-valves-100637068","NCT07614100","Cerebral Microembolization During Transcatheter Aortic Valve Implantation: Comparing Balloon-expandable and Self-expanding Valves","Cerebral Microembolization During Transcatheter Aortic Valve Implantation: A Randomized Study Comparing Balloon-expandable and Self-expanding Valves","MICROTAVI","Inclusion Criteria:\n\n* Age 18 years or older\n* Severe symptomatic aortic valve stenosis\n* Clinical indication for transcatheter aortic valve implantation\n* Feasibility of transcranial Doppler ultrasound monitoring\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Recent stroke or transient ischemic attack\n* Significant cerebrovascular disease preventing reliable transcranial Doppler -assessment\n* Previous aortic valve implantation\n* Active endocarditis\n* Pregnancy or breastfeeding",{"count":627,"type":21},80,[24],"This study will compare the amount of cerebral microembolization during transcatheter aortic valve implantation (TAVI) between two commonly used types of transcatheter aortic valves: balloon-expandable valves and self-expanding valves.\n\nCerebral microembolization refers to small particles or material that may travel to the brain during the procedure. These signals can be detected using transcranial Doppler ultrasound, a non-invasive method for monitoring blood flow in the brain. Although clinically apparent stroke after TAVI is relatively uncommon, small silent brain lesions may occur, and their mechanisms are not fully understood.\n\nAdult patients with severe symptomatic aortic valve stenosis who are scheduled for TAVI will be included. Participants will be randomly assigned to receive either a balloon-expandable or a self-expanding valve, both of which are established and routinely used treatment options. Transcranial Doppler monitoring will be performed before, during, and after the procedure to record the number of microembolic signals. The study will also record neurological events and procedural characteristics, such as procedure duration and the need for balloon dilatation.\n\nThe aim of the study is to determine whether the type of valve is associated with a different burden of cerebral microembolization during TAVI. The results may help improve understanding of procedural factors related to cerebral embolization and may support future strategies for reducing neurological risk in patients undergoing TAVI.",[27],[240,443,632],"Microembolism","2026-05-21",{"date":635,"type":35},"2026-05-29",{"date":540,"type":21},{"date":638,"type":21},"2027-02-01",{"name":640,"class":42},"Ivan Zeljkovic",{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":648,"targetDuration":503,"studyType":120,"phases":4,"briefSummary":650,"conditions":651,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":67},"100638048","active-post-market-surveillance-of-innovative-devices-for-valvular-heart-disease-100638048","NCT07605624","Active Post-Market Surveillance of Innovative Devices for Valvular Heart Disease","An Active Post-Market Surveillance Study Assessing the Real-World Clinical Applicability, Long-Term Safety, and Effectiveness of Innovative Medical Devices for Valvular Heart Disease","Inclusion Criteria:\n\n* Patients with valvular heart disease (VHD) receiving treatment with prosthetic aortic valve replacement systems (transcatheter and surgical valves), transcatheter mitral valve edge-to-edge repair (TEER) systems, or transcatheter tricuspid valve annuloplasty systems\n* Age ≥ 18 years\n* Patients who voluntarily participate in the study and sign the informed consent form\n* Willing and able to comply with follow-up requirements",{"count":649,"type":21},5500,"This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.",[27,652,83,560],"Aortic Regurgitation","2026-05-18",{"date":655,"type":35},"2026-05-26",{"date":657,"type":21},"2026-05-10",{"date":659,"type":21},"2029-01-31",{"name":661,"class":42},"Beijing Anzhen Hospital",{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":18,"minAge":469,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":671,"conditions":672,"keywords":674,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":67},"100627558","a-prospective-multicenter-observational-study-evaluating-safety-and-effectiveness-of-sapien-3-transcatheter-aortic-valve-replacement-for-type-0-bicuspid-aortic-valve-stenosis-patients-in-china-100627558","NCT07450196","A Prospective, Multicenter, Observational Study Evaluating Safety and Effectiveness of SAPIEN 3 Transcatheter Aortic Valve Replacement for Type-0 Bicuspid Aortic Valve Stenosis Patients in China","ASCENT","Inclusion Criteria:\n\n* Age ≥50 years, and after thorough physician-patient discussion and shared decision-making, willing to undergo or accept TAVR.\n* Severe AS, defined as follows:\n\n  a) For symptomatic patients: i) Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), OR mean gradient ≥40 mm Hg, OR Maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest b) For asymptomatic patients: i) Very severe AS with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND maximal aortic velocity ≥5.0 m\u002Fsec, or mean gradient ≥60 mm Hg by transthoracic echocardiography at rest, OR ii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND a mean gradient ≥40 mm Hg or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR iii) Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m\u002Fsec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction \\\u003C50%.\n* Type-0 bicuspid aortic valve anatomy confirmed by multi-detector computed tomography (MDCT).\n* The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.\n* Adequate iliofemoral access and acceptable level of vessel calcification and tortuosity for safe device implant.\n* The study patient has provided written informed consent.\n\nExclusion Criteria:\n\n* Challenging calcification based on physician's experience and discretion\n* Aortic valve is a congenital unicuspid valve, congenital Type-1 or Type-2 bicuspid valve, tricuspid or quadricuspid valve\n* Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR\n* Need for open heart surgery (including severe aortic regurgitation, mitral regurgitation or stenosis, or tricuspid regurgitation, congenital heart disease, AF, complex coronary artery disease)\n* Pre-existing mechanical or bioprosthetic valve in any position\n* Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit\n* Emergency interventional\u002Fsurgical procedures within 30 days of the valve implant procedure\n* Hypertrophic cardiomyopathy with obstruction\n* Ventricular dysfunction with LVEF \\\u003C 30%\n* Cardiac imaging (echo, CT, and\u002For MRI) evidence of ventricular mass, thrombus or vegetation\n* Renal replacement therapy at the time of screening\n* Estimated life expectancy \\\u003C 12 months\n* Currently participating in an investigational drug or another device study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary.",{"count":670,"type":21},170,"In China, bicuspid aortic valve (BAV) represents a significantly high proportion of the transcatheter aortic valve replacement (TAVR) population. The application of TAVR in patients with BAV is challenging due to complex anatomy. To date, no prospective study has evaluated the Sapien 3 TAVR in patients with Type-0 BAV.",[27,673],"AORTIC VALVE DISEASES",[675,159,296],"Balloon-expandable transcatheter heart valve","2026-05-03",{"date":678,"type":35},"2026-05-07",{"date":680,"type":21},"2026-04-15",{"date":682,"type":21},"2029-08-31",{"name":684,"class":42},"Chinese Academy of Medical Sciences, Fuwai Hospital"]