[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-valve-mv-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-valve-mv-regurgitation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,78,114,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100598298","abbott-cephea-mitral-valve-disease-registry-100598298",false,"NCT07069673","Abbott Cephea Mitral Valve Disease Registry","Inclusion Criteria:\n\n1. Symptomatic mitral valve disease resulting in mitral regurgitation and\u002For severe mitral valve stenosis.\n2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.\n3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, and heart failure.\n4. Age 18 years or older at time of consent.\n5. The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.\n2. Subject is undergoing dialysis or experiencing chronic renal failure\n3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use\n4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.\n5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.","ALL","18 Years",{"count":18,"type":19},1000,"ESTIMATED","2 Years","OBSERVATIONAL","The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.",[24,25,26,27,28,29,30],"Mitral Regurgitation","Mitral Stenosis","Mitral Valve Disease","Mitral Valve (MV) Regurgitation","Mitral Annulus Calcification","Mitral Valve Replacement","Transcatheter Valve Replacement",[26,32,33],"registry","Cephea Mitral Valve System","RECRUITING","2026-06-18",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":38},"2025-08-13",{"date":42,"type":19},"2028-12",{"name":44,"class":45},"Abbott Medical Devices","INDUSTRY",23,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100622231","catheter-ablation-for-af-in-patients-with-severe-mitral-regurgitation-after-successful-transcatheter-mitral-valve-repair-100622231","NCT07380932","Catheter Ablation for AF in Patients With Severe Mitral Regurgitation After Successful Transcatheter Mitral-Valve Repair","Inclusion Criteria:\n\n* Patients with documented atrial fibrillation (AF).\n* Transcatheter edge-to-edge mitral-valve repair (TEER) for severe functional mitral valve regurgitation (MR) with successful result (less than moderate MR, gradient \\\u003C 5 mmHg) performed within a period of minimum of 30 days and a maximum of 6 months. Moderate residual MR is eligible if no further mitral valve intervention or surgery is planned and patient is stable for \\> 3 months.\n* Provision of signed informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Patient not suitable for AF ablation\n* Previous ablation procedure for AF\n* Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrolment\n* Untreated hypothyroidism or hyperthyroidism requiring therapy\n* Enrolment in another randomised study\n* Indication for cardiac resynchronization therapy\n* Current pregnancy, breastfeeding, or women not using reliable contraceptive measures during fertility age\n* Mental or physical inability to participate in the study\n* Planned cardiovascular intervention or operation\n* Life expectancy ≤ 12 month",{"count":54,"type":19},956,"INTERVENTIONAL",[57],"NA","CABA-MiTRA-AFNET12 is a non-commercial, parallel-group, prospective, randomised, open, blinded endpoint assessment (PROBE), multi-centre, therapy strategy trial. The trial investigates patients with severe mitral valve regurgitation who have undergone transcatheter edge-to-edge mitral valve repair (M-TEER) and have concomitant atrial fibrillation (AF). The objective is to assess whether catheter ablation of AF is superior to standard-of-care treatment in patients after TEER in reduction of major adverse cardiovascular and cerebrovascular events (MACCE).",[60,27],"Atrial Fibrillation (AF)",[62,63,64,65],"Atrial fibrillation","Mitral valve regurgitation","Mitral valve repair","Catheter ablation","NOT_YET_RECRUITING","2026-01-23",{"date":69,"type":38},"2026-02-02",{"date":71,"type":19},"2026-07-01",{"date":73,"type":19},"2032-01-31",{"name":75,"class":76},"Atrial Fibrillation Network","OTHER",4,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":88,"conditions":89,"keywords":101,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100613478","cohort-observing-mechanisms-progression-and-sequelae-of-valvular-heart-disease-100613478","NCT07267117","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease","Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease (VALVE-COMPASS)","VALVE-COMPASS","Inclusion Criteria:\n\n* At least 18 years old;\n* Be willing and able to provide informed consent to participate in the study;\n* Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria:\n\n  1. Grade II or higher Aortic valve regurgitation: regurgitant jet width \\>3 mm, jet width \u002F LVOT diameter ≥25%, jet cross-sectional area\u002FLVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%.\n  2. Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m\u002Fs, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²\u002Fm², or velocity ratio ≤0.50.\n  3. Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area\u002Fleft atrial area \\>30%, or effective regurgitant orifice area (EROA) ≥0.2 cm².\n  4. Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg.\n  5. Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml.\n  6. Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral \\>60 cm, T1\u002F2 ≥190 ms, or valve area ≤1.0 cm².\n  7. Grade II or higher pulmonary valve regurgitation: regurgitant jet width \\>3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm².\n  8. Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening \\\u003C1.5 cm².\n\nExclusion Criteria:\n\n* Patients who are unwilling to accept registration and follow-up;\n* Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions;\n* Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).",{"count":87,"type":19},10000,"The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.",[90,27,26,91,92,93,94,95,96,97,30,98,99,100],"Heart Valve Disease","Mitral Valve Stenosis","Aortic Valve Disease","Aortic Valve Stenosis","Tricuspid Valve Disease","Tricuspid Valve Regurgitation","Aortic Valve Regurgitation","Pulmonary Valve Disease","Transcatheter Aortic Valve Replacement (TAVR)","Transcatheter Pulmonary Valve Replacement (TPVR)","Transcatheter Edge-to-edge Repair",[102,103],"Heart Valve Disease Progression","Heart Valve disease sequelae","2025-11-25",{"date":106,"type":38},"2025-12-05",{"date":108,"type":38},"2025-06-01",{"date":110,"type":19},"2030-05-31",{"name":112,"class":76},"Second Affiliated Hospital, School of Medicine, Zhejiang University",15,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":55,"phases":123,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100611639","dragonfly-m2-pivotal-study-100611639","NCT07243197","DragonFly M2 Pivotal Study","Safety and Performance Evaluation Study of DragonFly M2 System for Mitral Regurgitation","Inclusion Criteria:\n\n1.≥ 18 years old. 2.Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography.\n\n* Transseptal catheterization is determined to be feasible by the Investigator.\n* Patients have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF.\n\nExclusion Criteria:\n\n1)Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2) The presence of other severe heart valve disease requiring surgical intervention.\n\n3\\) Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.\n\n* Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.\n* In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.",{"count":122,"type":19},53,[57],"To confirm the effectiveness and safety of the DragonFly M2 Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects.The safety and effectiveness of the first-generation device(Dragonfly Transcatheter Mitral Valve Repair System)have been previously demonstrated. This study aims to further confirm the safety and effectiveness of the new device following structural optimization based on the first-generation design.",[27],"2025-11-17",{"date":128,"type":38},"2025-11-21",{"date":130,"type":19},"2026-01-15",{"date":132,"type":19},"2031-06-30",{"name":134,"class":45},"Hangzhou Valgen Medtech Co., Ltd",1,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":55,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":4},"100568630","highlife-clarity-treatment-of-severe-mitral-regurgitation-100568630","NCT06683729","HighLife Clarity Treatment of Severe Mitral Regurgitation","HIGHFIVE","Inclusion Criteria:\n\n* Based on local regulations, the subject meets the legal minimum age to provide informed consent\n* Moderate-to-severe or severe symptomatic MR (≥3+) by transthoracic echocardiography (TTE) which is primarily due to lack of mitral leaflet coaptation, secondary to either a) LV cardiomyopathy with restriction of the mitral leaflet(s), or b) mitral annular dilatation due to chronic atrial fibrillation or other cause, as confirmed by the echocardiographic core laboratory (note: some element of primary (degenerative) MR may be present, but the core lab must agree that the principal etiology is secondary MR)\n* New York Heart Association (NYHA) functional class II, III or ambulatory IV\n* Based on the assessment of the local multidisciplinary heart team, the patient is:\n\n  1. being treated with stable maximally-tolerated doses of guidelines class I indicated GDMT for at least one month, and CRT for at least 3 months (if applicable)\n  2. not indicated for heart surgery (mitral valve repair or replacement) according to guidelines and the local standard of care\n  3. unsuitable for treatment with transcatheter edge-to-edge repair (complex TEER anatomy) as assessed by the site interventional cardiologist(s)\n\nExclusion Criteria:\n\n* Any stroke or TIA within 30 days prior to procedure; any prior intracranial hemorrhage at any time; or any intracerebral mass, arteriovenous fistula or other malformation or defect predisposing to bleeding\n* Known severe carotid stenosis (\\>70% diameter stenosis by non-invasive imaging) or carotid stenting or carotid endarterectomy within 30 days)\n* History of bleeding diathesis, coagulopathy, clotting disorder, or refusal of future blood transfusion or bleeding in the 3 months prior to procedure other than minor cutaneous bleeding\n* Patients in whom transesophageal echo (TEE) is not feasible\n* Chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use.\n* Female subjects of childbearing potential who are not willing or able to comply with the use of contraception, or who are pregnant or lactating, or plan to get pregnant within the next 12 months.\n* Participation in another clinical study of an investigational drug or device at the time of inclusion that has not reached its primary endpoint\n* Patient has known allergies to the device components or contrast medium, which cannot be medically managed\n* Patient cannot tolerate anticoagulation (i.e. warfarin), or not willing to take anticoagulation for at least 6 months, or antiplatelet agents (i.e. aspirin, clopidogrel)\n* Patient with a life expectancy of less than 12 months, or otherwise is unable to comply with the follow-up schedule and assessments",{"count":144,"type":19},240,[57],"The purpose of the study is to evaluate the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-to-severe or severe mitral regurgitation (MR) who, by assessment of the local Heart Team, are unsuitable for treatment with approved transcatheter repair (sub-optimal results to complex or prohibitive edge-to-edge repair) or surgical mitral valve intervention according to guidelines.",[27],"2025-09-09",{"date":150,"type":38},"2025-09-15",{"date":152,"type":19},"2025-12-30",{"date":154,"type":19},"2034-06",{"name":156,"class":45},"HighLife SAS"]