[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mitral-regurgitation-functional\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mitral-regurgitation-functional":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,63,89,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100631634","early-feasibility-study-efs-of-the-nyra-cardiac-leaflet-enhancer-carlen-system-100631634",false,"NCT07503236","Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System","ENHANCE EFS: Early Feasibility Study (EFS) of the Nyra Cardiac Leaflet Enhancer (CARLEN) System","ENHANCE EFS","Key Inclusion Criteria:\n\n* Age \\> 21 years at time of enrollment\n* Patient has provided informed consent, is willing and capable of participating in all testing, and agrees to return for all required post-procedure follow-up visits\n* Moderate-to-severe or severe (MR ≥ 3+) functional (secondary) mitral valve regurgitation\n* Symptomatic with mitral regurgitation (NYHA Class II, III, or ambulatory IV) despite maximally-tolerated guideline-directed medical therapy (GDMT) as determined by the local multidisciplinary Heart Team\n* Patient is suitable for transcatheter mitral valve repair as determined by the local multidisciplinary Heart Team and confirmed by the Eligibility Committee\n\nKey Exclusion Criteria:\n\n* Estimated life expectancy of less than 12 months\n* Women who are pregnant, lactating, or planning to become pregnant during the clinical study. Women of child-bearing potential must have negative pregnancy test result within 2 weeks prior to the procedure\n* Left Ventricular Ejection Fraction (LVEF) \\\u003C 20%\n* Left ventricular end diastolic diameter (LVEDD) \\> 75 mm\n* Acute hemodynamic decompensation\n* Known hypersensitivity or contraindications to necessary and routine medications including contrast compounds or components used in the CARLEN System that cannot be successfully pre-medicated, including nitinol, an alloy of nickel and titanium\n* Contraindicated for transesophageal echo (TEE)\n* Presence of other anatomical characteristics and\u002For significant comorbidities that in the judgement of the Investigator or Eligibility Committee precludes the subject from participation\n* Aortic valve disease requiring intervention or intervention\n* Severe or greater tricuspid regurgitation\n* Severe right ventricular dysfunction\n* Severe pulmonary hypertension\n* Presence of significant congenital heart disease\n* Planned or scheduled cardiac surgery within next 12 months\n* Endocarditis within last 90 days\n* Evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease","ALL","21 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Safety and performance evaluation of the CARLEN System in patients with functional mitral valve regurgitation.",[27],"Mitral Regurgitation Functional","NOT_YET_RECRUITING","2026-04-06",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":21},"2026-06",{"date":36,"type":21},"2032-12",{"name":38,"class":39},"Nyra Medical, Inc.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":62},"100611636","randomized-controlled-study-of-dragonfly-system-for-functional-mitral-regurgitation-100611636","NCT07243158","Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation","A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of the DragonFly Transcatheter Mitral Valve Clip System in the Treatment of Moderate-to-Severe or Severe Functional Mitral Regurgitation (FMR)","Inclusion Criteria:\n\n1\\) Age ≥ 18 yrs. 2) Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy\n\n* Transseptal catheterization and femoral vein access is determined to be feasible.\n* The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.\n\nExclusion Criteria:\n\n1\\) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2）Echocardiography revealed severe restriction of leaflet motion due to tethering.\n\n3\\) The presence of other severe heart valve disease requiring surgical 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.","18 Years",{"count":49,"type":21},148,[24],"To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.",[27],"2025-11-17",{"date":55,"type":32},"2025-11-21",{"date":57,"type":21},"2025-12-30",{"date":59,"type":21},"2030-06-30",{"name":61,"class":39},"Hangzhou Valgen Medtech Co., Ltd",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":73,"conditions":74,"keywords":75,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":62},"100608089","early-phase-1-transcatheter-edge-to-edge-repair-in-moderate-and-exertional-induced-severe-mr-timer-100608089","NCT07197021","Transcatheter Edge-to-Edge Repair In Moderate and Exertional-Induced Severe MR (TIMER)","Inclusion Criteria:\n\n1. Moderate functional mitral regurgitation\n2. HG-induced severe functional mitral regurgitation\n3. Left ventricular ejection fraction (LVEF) between 20% to 50%\n4. Left ventricular end-systolic diameter (LVESD) ≤70 mm\n\nExclusion Criteria:\n\n1. Stage D heart failure per ACC\u002FAHA guidelines with hemodynamic instability or cardiogenic shock\n2. Untreated symptomatic coronary artery disease requiring revascularization\n3. Chronic obstructive pulmonary disease (COPD) requiring continuous oxygen therapy or long-term corticosteroids therapy\n4. Severe pulmonary hypertension or moderate-to-severe right ventricular dysfunction\n5. Aortic or tricuspid valve disease requiring surgical or transcatheter intervention\n6. Life expectancy \\\u003C12 months",{"count":70,"type":21},300,[72],"EARLY_PHASE1","Transcatheter Edge-to-Edge Repair (TEER) has become an established alternative for the treatment of severe mitral regurgitation (MR). RESHAPE trial indicated that patients with moderate functional MR (FMR) and heart failure (HF) might benefit from TEER. However, it still not clear that TEER is effective for which subset of patients with FMR.\n\nHand-Gripping (HG), characterized with an increased venous return, preservation or increase of left ventricular (LV) afterload and systemic vascular resistance, has been identified as a means of stress test to identify exertion-induced mitral regurgitation. Most importantly, compared to exercise stress testing via treadmill running or cycling in patients with moderate FMR, HG demonstrates significantly higher feasibility and safety.\n\nHG-induced severe MR reflects the reversibility of the regurgitation under stress, suggesting that reducing MR through TEER might alleviate LV volume overload, improve cardiac efficiency, and mitigate symptoms, which need to be validated in this trial.\n\nTIMER is a multi-center, randomized, double blind, placebo-controlled trial. A total of 300 patients with moderate and exertional-induced severe MR will be randomized in a 1:1 ratio to the treatment with TEER and guideline-directed medical therapy (GDMT) or GDMT only.\n\nThe primary endpoint of this study is rehospitalization within 24 months.",[27],[76,77,78],"hand grip","TEER","moderate","2025-09-20",{"date":81,"type":32},"2025-09-29",{"date":83,"type":21},"2025-10-01",{"date":85,"type":21},"2030-09-30",{"name":87,"class":88},"Sun Yat-sen University","OTHER",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":97,"targetDuration":99,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":62},"100570075","optimizing-clinical-outcomes-in-patients-undergoing-mitral-transcatheter-edge-to-edge-repair-m-teer-for-severe-functional-mitral-regurgitation-towards-improved-guideline-directed-medical-therapy-100570075","NCT06702527","Optimizing Clinical Outcomes in Patients Undergoing Mitral Transcatheter Edge-to-edge Repair (M-TEER) for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy","Optimizing Clinical Outcomes in Patients Undergoing M-TEER for Severe Functional Mitral Regurgitation Towards Improved Guideline-directed Medical Therapy - The MOTOR Registry","MOTOR","Inclusion Criteria:\n\n* mitral transcatheter edge-to-edge repair (M-TEER) patients treated with the PASCAL system (≥ 18 years) as per the current approved indication and local Heart Team decision\n* Severe functional and mixed-type mitral regurgitation with LV-EF \\\u003C 50%\n* Patient with optimized guideline-directed medical therapy (GDMT): A minimum of 3 points in the pre-defined GMDT scoring system\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Degenerative mitral regurgitation\n* Emergency procedure\n* Re-do or concomitant (mitral\u002Ftricuspid) procedures\n* Patients on maximum dose GDMT\n* Atrial functional mitral regurgitation (FMR)\n* Coronary revascularisation within the last 3 months\n* Pregnant woman",{"count":98,"type":21},100,"12 Months","OBSERVATIONAL","A multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. This maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. Researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.",[27,103,104],"Heart Failure","M-TEER",[106,103,104,107,108],"Mitral Regurgitation","Optimizing GDMT","Functional Mitral Regurgitation","2025-05-20",{"date":111,"type":32},"2025-05-23",{"date":113,"type":21},"2025-06-01",{"date":115,"type":21},"2026-09-01",{"name":117,"class":118},"Institut für Pharmakologie und Präventive Medizin","NETWORK",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":131,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":62},"100418798","safety-and-effectiveness-study-of-dragonfly-system-for-functional-mitral-regurgitation-100418798","NCT04733404","Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation","A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Functional Mitral Regurgitation (FMR) Subjects.","Inclusion Criteria:\n\n1. Age ≥ 18 yrs.\n2. Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy Note 1: Functional MR requires the presence of overall or localized LV wall motion abnormalities that are considered to be the primary cause of MR. Despite the eligibility, subjects may not enroll if leaflet prolapse or other evidence of degenerative MR is present.\n\n   Note 2: An Eligible transthoracic echocardiography must be obtained at least 30 days after the subject has been stabilized on optimal therapy with Guideline Directed Medical Therapy (GDMT), and after meeting two of the following conditions:\n   1. GDMT dose increase of no greater than 100% or decrease of no greater than 50%.\n   2. Coronary revascularization and\u002For implantation of a cardiac resynchronization therapy device (CRT or CRT-D) or reprogramming of the implanted CRT or CRT-D resulting in an increase in biventricular pacing (from \\\u003C92% to ≥92%).\n3. Subjects have been adequately treated according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), coronary revascularization, and\u002For have received stable GDMT, as defined in (Appendix IV: Definition of GDMT), confirmed by the local heart team.\n4. NYHA functional class II to IVa.\n5. Left ventricular ejection fraction (LVEF) ≥ 20% and ≤50%.\n6. Left ventricular end-systolic dimension (LVESD) ≤ 70 mm.\n7. Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the DragonflyTM device.\n8. Elevated BNP \\>150 pg\u002Fml or corrected NT-proBNP ≥600 pg\u002Fml or heart failure hospitalization within the past 12 months ('corrected' refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg\u002Fm2 in BMI above a reference BMI of 20 kg\u002Fm2).\n9. Transseptal catheterization and femoral vein access is determined to be feasible.\n10. The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.\n\nExclusion Criteria:\n\n1. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.\n2. The presence of other severe heart valve disease requiring surgical intervention.\n3. Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.\n4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.), or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.\n5. Moderate to severe right heart dysfunction or an estimated pulmonary artery systolic pressure (PASP) \\> 70 mmHg assessed by echocardiography.\n6. History of acute myocardial infarction in the prior 4 weeks or untreated clinically significant coronary artery disease requiring revascularization.\n7. Any percutaneous cardiac intervention within the 30 days, or any cardiac surgery within the 6 months prior to randomization, or any implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) or Implantable Cardioverter Defibrillator (ICD) within the last 30days prior to subject registration.\n8. In the judgment of the investigator, the subject's femoral vein is unable to accommodate a 25F catheter or has an ipsilateral deep venous thrombosis; or the anatomy is not accessible for transseptal puncture.\n9. Subjects in whom transesophageal echocardiography (TEE) or general anesthesia is contraindicated.\n10. End-stage heart failure (ACC\u002FAHA stage D), or prior orthotopic heart transplantation, or on the waiting list for heart transplantation.\n11. Active endocarditis, or active rheumatic heart disease, or leaflets degenerated from either endocarditis or rheumatic disease.\n12. Severe Chronic Obstructive Pulmonary Disease (COPD) (requiring continuous home oxygen therapy or long-term application of steroid hormone medication).\n13. Cerebrovascular accident within 30 days prior to randomization or symptomatic severe carotid stenosis (\\> 70% by ultrasound), or carotid artery stenting within 30 days.\n14. Evidence of acute peptic ulcer or gastrointestinal hemorrhage in the prior 3 months.\n15. Hemorrhagic or coagulopathic disorders, contraindications to antithrombotic medication.\n16. Modified Rankin Scale ≥4.\n17. The subjects suffer from diseases that may lead to difficulty in evaluating treatment (e.g., cancer, severe metabolic disease, psychosis, etc.).\n18. Pregnant or breastfeeding women, or women who plan to become pregnant within the next 12 months. Note: Women of childbearing age should take a pregnancy test with a negative result within 14 days prior to registration and use scientifically safe contraception\n19. Hemodynamic instability defined as systolic pressure \\\u003C 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or an intra-aortic balloon pump.\n20. Active infections requiring antibiotic therapy (in the case of temporary illness, antibiotics must be discontinued for at least 14 days before the subject can be enrolled).\n21. 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.\n22. 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":127,"type":21},120,[24],"To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.",[27],"RECRUITING","2022-03-26",{"date":134,"type":32},"2022-03-29",{"date":136,"type":32},"2022-03-12",{"date":138,"type":21},"2027-09-30",{"name":61,"class":39}]