[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrial-functional-mitral-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrial-functional-mitral-regurgitation":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,80,105,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100634408","phase-2-effects-of-valsartan-on-atrial-mitral-regurgitation-100634408",false,"NCT07539298","Effects of VALsartan On atRIAl Mitral Regurgitation","Effects of VALsartan On atRIAl Mitral Regurgitation: A Pilot Randomized Controlled Trial","VALORIA","Inclusion Criteria:\n\n1. No evidence of mitral organic disease\n2. At least moderate left atrial dilatation (left atrial volume index ≥34 mL\u002Fm²)\n3. Normal (≥ 50%) left ventricular ejection fraction and\n4. At least moderate MR grade by multiparametric assessment.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Indication for or ongoing treatment with ACEI\u002FARB\n3. History of hypotension\n4. Hypertension (\\>140\u002F90 mmHg) \\*\n5. Planned cardiac surgery (CABG or valve)\n6. Ongoing or planned pregnancy\n7. Chronic renal failure with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m2\n8. Neurocognitive disorder\n9. History of hyperkalemia\n10. Medication interacting with valsartan","ALL","18 Years","85 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","The goal of this clinical trial is to learn whether valsartan can slow the progression of atrial functional mitral regurgitation (AFMR) in adults with preserved left ventricular ejection fraction. The study will also evaluate the safety and tolerability of valsartan in this population.\n\nThe main questions it aims to answer are:\n\n* Does treatment with valsartan reduce the progression of atrial functional mitral regurgitation compared with placebo?\n* Does valsartan have favorable effects on mitral valve leaflet remodeling and related cardiac structure and function?\n* Is valsartan safe and well tolerated in patients with atrial functional mitral regurgitation who do not currently require angiotensin-converting enzyme inhibitors or angiotensin receptor blockers?\n\nResearchers will compare valsartan to a placebo (a look-alike substance with no active drug) to see if valsartan reduces the progression of atrial functional mitral regurgitation and improves clinical and imaging outcomes.\n\nParticipants will:\n\n* Take valsartan or placebo twice daily for 12 months, with dose adjustments based on blood pressure, kidney function, and tolerance\n* Undergo 3D echocardiography at baseline, 6 months, and 12 months\n* Complete a 6-minute walk test at baseline and 12 months\n* Complete the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 6 months, and 12 months\n* Undergo 24-hour ambulatory blood pressure monitoring at 1 month\n* Have regular safety monitoring, including phone follow-up at 7 days, blood tests at 1 month, and blood pressure checks after dose adjustments",[29],"Atrial Functional Mitral Regurgitation",[31,32,33,34,35,36],"mitral regurgitation","Atrial functional mitral regurgitation","valsartan","placebo","mitral valve leaflets","randomized, double-blind, placebo-controlled clinical trial","NOT_YET_RECRUITING","2026-05-07",{"date":40,"type":41},"2026-05-12","ACTUAL",{"date":43,"type":22},"2026-05-01",{"date":45,"type":22},"2029-12-01",{"name":47,"class":48},"Jonathan Beaudoin","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100584017","efficacy-and-safety-of-catheter-ablation-in-patients-with-severe-mitral-regurgitation-and-persistent-atrial-fibrillation-a-randomized-controlled-trial-100584017","NCT06883864","Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial","Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial(ELEVATE-AF)","ELEVATE-AF","Inclusion Criteria:\n\n1. Patients were required to have moderate-to-severe or greater (≥3+) atrial functional mitral regurgitation assessed by transthoracic echocardiography within 14 days before randomization. Mitral regurgitation severity was graded by an echocardiography core-lab based on the American Society of Echocardiography criteria, specifically an effective regurgitant orifice area (EROA) ≥30 mm²\n2. Age 18-80 years\n3. Persistent atrial fibrillation diagnosed by electrocardiogram\n4. Left ventricular ejection fraction ≥50% assessed by transthoracic echocardiography within 14 days before randomization(confirmed by the echocardiography core-lab)\n5. Left ventricular end-diastolic internal diameter ≤60 mm and left atrial anterior- posterior diameter ≤60 mm in echocardiographic parasternal long-axis view within 14 days before randomization(confirmed by the echocardiography core-lab)\n6. Agree to undergo catheter ablation and be able to undergo follow-up as required.\n\nExclusion Criteria:\n\n1. paroxysmal atrial fibrillation, atrial fibrillation secondary to an apparently reversible cause, or with history of previous ablation;\n2. primary mitral valve pathology, including calcification, sclerosis, prolapse, flail, tendon cable rupture, valve degeneration, infective endocarditis, rheumatic lesions, or ischemic lesions;\n3. history of previous mitral valve surgery or transcatheter manipulation;\n4. mitral valve orifice area \\\u003C4 cm2;\n5. aortic valve disease requiring surgical or transcatheter intervention;\n6. untreated clinically significant coronary artery disease requiring revascularization;\n7. history of previous myocardial infarction;\n8. previous definitive diagnosis of cardiomyopathies such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, arrhythmogenic cardiomyopathy, and infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, and nodular disease)\n9. echocardiographic evidence of intracardiac mass or thrombus;\n10. implant of cardiac device (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device, or left atria appendage closure);\n11. hemodynamic instability requiring cardiac assist devices, intra-aortic balloon pump (IABP), or other hemodynamic support;\n12. any percutaneous cardiac intervention (percutaneous coronary intervention, transcatheter aortic valve replacement, etc.) within the 30 days prior to randomization,\n13. any cardiac surgery within the 6 months prior to randomization;\n14. active infections requiring current antibiotic therapy;\n15. a known hypersensitivity or contradiction to procedure medications which cannot be adequately managed medically;\n16. contraindication to appropriate anti-coagulation therapy;\n17. chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic oral steroid therapy;\n18. acute cerebrovascular accident within 30 days prior to randomization or Modified Rankin Score ≥ 4;\n19. symptomatic severe carotid stenosis (\\>70% by ultrasound);\n20. other planned surgical or interventional procedures within the next 3 months;\n21. liver failure;\n22. renal failure or dialysis status;\n23. pregnant or planning pregnancy within the next 3 months;\n24. life expectancy \\\u003C 12 months (e.g., advanced malignant tumors);\n25. currently participating in other interventional studies;\n26. circumstances that, in the judgment of the researcher, make participation in this study unsuitable.","80 Years",{"count":59,"type":22},146,[61],"NA","Atrial fibrillation (AF) leads to atrial functional mitral regurgitation (MR) through mechanisms including mitral annular dilatation, systolic leaflet motion distance alteration, and contractility decrease. Compared with primary MR, atrial functional MR due to AF and other diseases tends to have a worse prognosis, with a higher risk of death and heart failure hospitalization. MR and AF co-exist and exacerbate left atrial dysfunction, further causing worse cardiac dysfunction, valvular regurgitation, and aggravating prognosis.\n\nThe best therapy for secondary MR is unclear because MR is only one component of the disease, and restoration of mitral valve competence is not curative. Catheter ablation improves symptoms and cardiac function in patients with AF, reduces risks of AF recurrence and hospitalization, as well as increases quality of life. For patients with AF combined with functional moderate-to-severe MR, previous observational studies have found that the severity of MR significantly reduced after taking catheter ablation to restore sinus rhythm. We hypothesized that catheter ablation would significantly improve the severity of MR in patients with severe atrial functional MR combined with persistent AF compared with drug therapy alone.",[64,65,29],"Atrial Fibrillation (AF)","Catheter Ablation",[67,31,68],"atrial fibrillation","catheter ablation","RECRUITING","2026-03-11",{"date":72,"type":41},"2026-03-13",{"date":74,"type":41},"2025-04-08",{"date":76,"type":22},"2028-05-01",{"name":78,"class":48},"Beijing Anzhen Hospital",17,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100624791","safety-and-efficacy-of-transcatheter-edge-to-edge-repair-for-atrial-functional-mitral-regurgitation-100624791","NCT07414225","Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation","Safety and Efficacy of Transcatheter Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation - The STAR Trial","STAR","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Echocardiographic core laboratory criteria (all must be present):\n\n   1. Atrial FMR (FMR must be atrial in etiology without ventricular leaflet tethering)\n   2. Severe MR (3+ or 4+) defined as either 1) an effective regurgitant orifice area (EROA) ≥0.3 cm² or pulmonary-venous systolic flow reversal (PSVFR), or 2) in the absence of PSVFR, EROA measures 0.20-0.29 cm² with one or more of the following: regurgitant volume ≥45 mL\u002Fbeat, regurgitant fraction ≥40%, or vena contracta width ≥0.5 cm.\n   3. LV ejection fraction ≥50% without more than mild regional wall motion abnormalities\n   4. No or mild LV dilatation (LV end-diastolic volume index \\\u003C79 mL\u002Fm2 \\[male\\] or \\\u003C71 mL\u002Fm² \\[female\\])\n   5. Left atrial dilation (left atrial volume index ≥34 mL\u002Fm²)\n   6. Mitral annulus dilatation (AP diameter \\>35mm)\n3. The mechanism of the atrial FMR is likely either atrial fibrillation (persistent\u002Fpermanent or paroxysmal \\[documented\\]) and\u002For HFpEF. If HFpEF, one or both of the following must also be present:\n\n   1. TTE criteria of diastolic dysfunction i. Average E\u002Fe' ≥15, or ii. Average E\u002Fe' 9-14 plus both of the following:\n\n1\\. Septal e' \\\u003C7 cm\u002Fs or lateral e' \\\u003C10 cm\u002Fs 2. TR Vmax \\>2.8 m\u002Fs (or PASP \\>35 mmHg if TR jet is adequate) AND\u002FOR b) Invasive hemodynamic evidence (measured prior to randomization) of elevated LV filling pressures (PCWP (or LVEDP) ≥15 mmHg at rest or ≥25 mmHg with exercise; Note: If PCWP is 12 to 15 mmHg, the patient may be given a 7-10 mL\u002Fkg (approximately 500 mL) rapid infusion (over 5-10 min) of normal saline; if PCWP rises to ≥18 mmHg, the subject may be randomized.\n\n4\\. NT-proBNP ≥300 pg\u002FmL (or BNP ≥100 pg\u002FmL) if at the time of the test the patient is in sinus rhythm or NT-proBNP ≥600 pg\u002FmL (or BNP ≥200 pg\u002FmL) if the patient is in atrial fibrillation 5. Subject remains symptomatic (NYHA class II, III or ambulatory IV) despite maximally tolerated doses of societal indicated class I GDMT for ≥2 months\n\na) Diuretics as needed to treat pulmonary congestion and peripheral edema b) If atrial fibrillation: Rate control medication to ensure heart rate \\\u003C110 bpm c) If HFpEF: i. SGLT2i for at least 2 months (required) ii. MRAs, e.g., spironolactone or finerenone) and angiotensin receptor-neprilysin inhibitors (ARNIs, e.g., sacubitril\u002Fvalsartan) may be used at the discretion of each center (but should not be changed after randomization) 6. SBP \\\u003C140 mmHg and HR \\\u003C100 bpm (\\\u003C110 bpm if in atrial fibrillation) 7. Atrial fibrillation ablation is determined by the local heart team. If ablation is deemed necessary, it will be performed prior to enrollment; if ablation is considered unsuitable, no ablation will be performed after enrollment.\n\n8\\. Anatomy suitable for TEER 9. The subject or legal guardian voluntarily agrees to comply with all provisions of this clinical trial, including the possibility of being randomly assigned to the control group, as well as participating in all necessary postoperative follow-ups and provides written informed consent.\n\nExclusion Criteria:\n\n1. Patient is clinically unstable or has been hospitalized within the prior 30 days.\n2. Primary degenerative or organic mitral valve disease such as prolapse, Barlow's disease, rheumatic heart valve disease causing leaflet thickening, leaflet clefts or perforation, endocarditis, etc. Note: A small amount of mitral leaflet thickening or other abnormality may be present, but it cannot be the primary cause of MR.\n3. Moderate or severe mitral annular calcification, or any degree of mitral annular calcification if it is the primary cause of the MR or would interfere with TEER.\n4. Mitral valve area (MVA) \\\u003C4.0 cm² or mean trans-mitral valve gradient \\>4 mmHg.\n5. Intent to treat the patient with mitral valve surgery within the next 24 months if randomized to control\n6. Known cardiomyopathy such as amyloid, sarcoid or hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, or pericardial diseases such as constrictive pericarditis.\n7. Previous mitral valve surgery or transcatheter mitral valve intervention.\n8. Any severe valvular disease of the pulmonary valve or tricuspid valve, or moderate or severe disease of the aortic valve.\n9. Moderate or severe right ventricular dysfunction, defined as TAPSE≤14mm or RVFAV≤30% on the baseline echo.\n10. Severe pulmonary hypertension defined as RVSP≥70mmHg on the baseline echo.\n11. AF ablation procedure within 2 months prior to enrollment.\n12. Any implantation of an intracardiac pressure monitoring system, baroreceptor activation therapy, cardiac contractility modulation within 2 months prior to enrollment or planned any time after enrollment.\n13. If taking a chronic oral anticoagulation: Inability to discontinue it for several days prior to the procedure\n14. If not taking a chronic oral anticoagulation: Inability to tolerate aspirin or clopidogrel for 6 months\n15. Untreated clinically significant coronary artery disease requiring revascularization\n16. Coronary artery bypass grafting (CABG) within prior 30 days\n17. Percutaneous coronary intervention (PCI) within prior 30 days\n18. Acute cerebrovascular event within prior 30 days or any prior intracranial hemorrhage\n19. Allergic to heparin or any study drug that cannot be pre-medicated\n20. Any contraindication to transesophageal echocardiography\n21. IVC filter in place\n22. Any atrial septal pathology interfering with mitral TEER (e.g. atrial septal aneurysm, device in place across the atrial septum, etc.)\n23. Any major surgery within prior 30 days or anticipated within 24 months\n24. Non-cardiac disease with a life expectancy \\\u003C24 months",{"count":89,"type":22},400,[61],"This study is a prospective, randomized, parallel-control, open-label, multicenter clinical trial. Eligible subjects will be randomized in a 1:1 ratio to the Device group (Interventional group) or to no Device group (Control Group). The objective is to identify the safety and effectiveness of the TEER for the treatment of moderate-to-severe (3+) or severe (4+) atrial functional mitral regurgitation (aFMR) in patients who are symptomatic despite maximally tolerated guideline directed medical therapy.",[29],[31,94,95,67],"heart failure with preserved ejection fraction","transcatheter edge-to-edge repair","2026-02-10",{"date":98,"type":41},"2026-02-17",{"date":100,"type":22},"2026-02-25",{"date":102,"type":22},"2030-02-25",{"name":78,"class":48},1,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100586109","assessment-of-transcatheter-edge-to-edge-repair-in-atrial-functional-mitral-regurgitation-atrial-mr-100586109","NCT06911099","Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation (ATRIAL-MR)","Assessment of Transcatheter Edge-to-Edge Repair in Atrial Functional Mitral Regurgitation","Inclusion Criteria:\n\n* functional mitral regurgitation\n* left ventricular ejection fraction ≥50%\n\nExclusion Criteria:\n\n* age under 18 years\n* known regional wall movement disorders",{"count":113,"type":22},1000,"OBSERVATIONAL","This investigator-initiated, multicenter, international, retrospective registry aims to investigate outcomes of patients with atrial functional mitral regurgitation, as treated in clinical routine.",[29,117],"Mitral Insufficiency",[119,120,121,122,123,124],"atrial functional mitral regurgitation","AFMR","atrial secondary mitral regurgitation","ASMR","mitral valve transcatheter edge-to-edge repair","M-TEER","2025-04-03",{"date":127,"type":41},"2025-04-06",{"date":129,"type":41},"2010-01-01",{"date":131,"type":22},"2035-12-31",{"name":133,"class":48},"University Hospital of Cologne",22,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":120,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":142,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":104},"100564573","study-of-atrial-fibrillation-combined-with-atrial-functional-mitral-regurgitation-100564573","NCT06630936","Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation","Prospective Multi-Center Cohort Study of Atrial Fibrillation Combined with Atrial Functional Mitral Regurgitation","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years old;\n2. Patients diagnosed with symptomatic paroxysmal atrial fibrillation (AF history \\< 5 years)\n3. Moderate to severe MR and normal LV ejection fraction (≥50%), LVEDD\\<55 mm, and normal LV wall systolic function\n4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the subject him\u002Fherself or his or her legal representative, and willing to complete follow-up visits as required under the protocol\n\nExclusion Criteria:\n\n1. Atrial fibrillation secondary to electrolyte imbalances, thyroid disease or other reversible factors\n2. Active endocarditis or active rheumatic heart disease, or degenerative mitral regurgitation due to endocarditis or rheumatic valvular heart disease\n3. Moderate to severe mitral stenosis\n4. Imaging examination shows left atrium or left atrial appendage thrombosis\n5. Left ventricular ejection fraction less than 50%\n6. Left atrial diameter more than 50mm\n7. Patients with previous left atrial appendage occlusion or left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure or repair (only applied for patients who need to ablation)\n8. Patients who have implanted devices such as implantable cardioverter defibrillator(ICD), cardiac resynchronization therapy(CRT) or pacemaker\n9. Previous metal artificial valve or valve repair device implantation (only applied for patients who need to ablation)\n10. Presence of lateral thrombus, tumors or other abnormalities that interfere with vascular puncture or catheter operation (only applied for patients who need to ablation)\n11. Anticoagulation contraindications, and history of blood clotting or bleeding abnormalities\n12. Acute systemic infection\n13. Female patients who are pregnant, lactating, or unable to use contraception during the study\n14. Patients' life expectancy is less than 12 months\n15. Abnormalities or diseases that the investigator believes should be excluded from the scope of enrollment in this study",{"count":143,"type":22},500,"To evaluate the improvement of mitral regurgitation after catheter ablation of atrial fibrillation or regular drug therapy in atrial fibrillation patients combined with atrial functional mitral regurgitation.",[64,29],[147,29,68],"Atrial Fibrillation","2024-11-21",{"date":150,"type":41},"2024-11-22",{"date":152,"type":41},"2024-09-27",{"date":154,"type":22},"2026-09-30",{"name":156,"class":48},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]