[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"degenerative-mitral-valve-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:degenerative-mitral-valve-disease":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,69,91],{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100637625","transcatheter-vs-surgical-treatment-of-degenerative-mitral-regurgitation-100637625",false,"NCT07605715","Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation","Transcatheter vs. Surgical Treatment of Degenerative Mitral Regurgitation: A Comparative Study of Clinical Outcomes, Patient Experiences, and Mechanistic Insights With Multimodality Imaging","DMR","Inclusion Criteria:\n\n* Patients older than 60 years who have DMR will be included in the study\n\nExclusion Criteria:\n\n* Patients with prior history of mitral intervention or surgery will be excluded.\n* Patient records flagged \"break the glass\" or \"research opt out\" will be excluded.\n* Persons with allergy to animal dander or animal-instigated asthma will be excluded.","ALL","60 Years",{"count":20,"type":21},60,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to compare the outcomes of transcatheter edge-to-edge repair (TEER) versus surgical mitral valve repair for degenerative mitral regurgitation (DMR) over the long term. The study aims to:\n\n1. Evaluate the effectiveness and safety of TEER versus surgery in patients with DMR over long term.\n2. Investigate the predictors of left ventricular dysfunction and clinical outcomes using advanced imaging techniques, such as cardiac MRI\n3. Assess patient-reported recovery and quality of life outcomes using validated tools.\n\nThe study focuses on improving care strategies for patients with DMR, particularly those at higher surgical risk, by identifying optimal treatment approaches and predictors of recovery.",[25],"Degenerative Mitral Valve Disease",[27,28,29],"TEER","Transcatheter mitral repair","Surgical mitral repair","RECRUITING","2026-05-18",{"date":33,"type":34},"2026-05-26","ACTUAL",{"date":36,"type":34},"2025-02-19",{"date":38,"type":21},"2027-08",{"name":40,"class":41},"Cedars-Sinai Medical Center","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100489651","safety-and-efficacy-of-the-geminione-transcatheter-valve-edge-to-edge-repair-system-in-patients-with-moderate-severe-or-severe-degenerative-mitral-regurgitation-100489651","NCT05655897","Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation","A Prospective, Multicentric Clinical Trial Protocol to Evaluate the Safety and Efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System for the Treatment of Moderate-severe or Severe Degenerative Mitral Regurgitation With Single-arm Objective Performance Criteria","Inclusion Criteria:\n\n1. Patients who volunteer to participate and sign an informed consent form, understand the purpose of the clinical trial and are able to cooperate throughout the trial process;\n2. An age ≥ 18 years;\n3. Diagnostic transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days to determine the presence of symptomatic moderate-severe or severe degenerative mitral regurgitation (defined as mitral regurgitation grade ≥3+);\n4. Patients' New York Heart Association (NYHA) cardiac function classification (see Appendix II) in grades II, III, or non-ambulatory grade IV；\n5. Patients' left ventricular ejection fraction LVEF ≥ 20%;\n6. Patients considered to be at high surgical risk by the multidisciplinary cardiac team ;\n7. Patients are anatomically suitable for mitral valve repair and suitable for the device under this study as assessed by the multidisciplinary cardiac team;\n\nElements include, however, are not constrained to the following:\n\n1. Mitral valve orifice area ≥ 4.0 cm2;\n2. Left ventricular end-systolic dimension (LVESD) ≤ 60 mm;\n3. The primary regurgitant bundle is a non-conjunctive regurgitant bundle and if the secondary regurgitant bundle is present, must be clinically insignificant;\n4. Transeptal puncture and femoral venipuncture are feasible; The recommended reference criteria for high surgical risk are: an STS score of ≥8 for surgical valve replacement (see Appendix III) or an STS score of ≥6 for surgical valve repair, or the existence of other high-risk factors, such as the presence of other high-risk elements such as the presence of ≥ 2 warning signs of moderate-severe frailty or the presence of feasible surgical operative limitations or the presence of ≥ 2 main organs dysfunctions that cannot be elevated postoperatively or other surgical high-risk factors that are genuinely existing in the judgment of the independent cardiac surgeon in this study.\n\nExclusion Criteria:\n\n1. The presence of intra-cardiac space occupancy, thrombus, or bulky organisms as indicated by echocardiography;\n2. The presence of other severe heart valve diseases requiring surgical intervention;\n3. Leaflet anatomy that may prevent implantation of the valve clip, proper positioning on the leaflet, or prevent adequate reduction of mitral regurgitation by the valve clip. The assessment is based on transesophageal echocardiographic (TEE) mitral valve evaluation within 180 days prior to the subject's registration and includes:\n\n   1. inability of the valve clips to hold sufficient active leaflets;\n   2. lack of primary and secondary tendon support in the clamping area;\n   3. significant evidence of calcification in the clamping area;\n   4. significant fissures in the clamping area;\n4. Active endocarditis, pericarditis, or rheumatic heart disease; or mitral valve leaflet changes resulting from endocarditis or rheumatic heart disease;\n5. Severe right ventricular insufficiency (e.g. with symptoms of bilateral lower limb edema with increased jugular venous pressure and hepatomegaly); or pulmonary hypertension (pulmonary artery systolic pressure PASA \\> 70 mmHg as measured by echocardiography);\n6. Patients who have had an acute coronary syndrome within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization;\n7. Patients with any cardiovascular intervention, cardiac surgery, cardiac resynchronization therapy (CRT, CRT-D), implantation of a buried cardioverter-defibrillator (ICD), etc. within 30 days; or have planned one of these procedures;\n8. Patients underwent mitral valve surgery or mitral transcatheter valve surgery before, or have a left atrial appendage occluder device inside；\n9. Patients with end-stage heart failure (ACC\u002FAHA stage D), or after cardiac transplantation, or awaiting cardiac transplantation;\n10. Patients who are hemodynamically unstable, defined as systolic blood pressure \\\u003C90 mmHg without postload-reducing drugs, or in cardiogenic shock; or are requiring intra-aortic balloon counterpulsation, or other hemodynamic support drugs or devices;\n11. Patients requiring emergency or urgent surgery for any reason;\n12. Patients' femoral vein cannot accommodate a 22F catheter or overlaying ipsilateral deep venous thrombosis, as assessed by the investigator, or are anatomically unsuitable for atrial septum puncture; \\[13\n13. Patients with active infection requiring concurrent antibiotic treatment; in the case of temporary disease, antibiotics must be discontinued for at least 14 days before enrollment;\n14. Patients with a history of any cerebrovascular accident within 30 days; or a severe symptomatic carotid stenosis (carotid ultrasound suggesting \\>70% stenosis);\n15. Modified Rankin Scale score ≥ 4 (see Annex IV);\n16. Patients with a history of acute peptic ulcer or gastrointestinal bleeding within 3 months;\n17. Patients with hematological cachexia, including granulocytopenia (WBC \\\u003C3 x 109\u002FL), anemia (HB \\\u003C 90 g\u002FL), thrombocytopenia (PLT \\\u003C50 x 109\u002FL), bleeding disorders, and coagulopathy; or the presence of contraindications to antiplatelet or anticoagulant medication;\n18. Patients with a contraindication to transesophageal echocardiography; or a contraindication to general anesthesia；\n19. Patients with severe chronic obstructive pulmonary disease (COPD) requiring long-term steroids or continuous home oxygen therapy；\n20. Patients with severe hepatic or renal insufficiency (ALT, AST, creatinine \\> 2 times the upper limit of normal values)；\n21. Pregnant or lactating women, or those with a birth plan within 12 months；\n22. Patients with known hypersensitivity to device components or contrast media；\n23. Patients enrolled in another clinical study and within the follow-up period；\n24. Patients with a disease that would make the evaluation of treatment difficult (e.g. cancer, infection, severe metabolic disease, psychiatric disease, etc.); or patients with a life expectancy shorter than 12 months；\n25. Patients whose compliance is assessed by the investigator to be poor and are unable to comply with the follow-up schedule and complete the examination; or other situations in which the investigator considers the issue to be unsuitable for participation in the study.","18 Years",{"count":52,"type":21},120,"INTERVENTIONAL",[55],"NA","To observe and evaluate the safety and efficacy of the GeminiOne Transcatheter Valve Edge-to-Edge Repair System in Patients With Moderate-severe or Severe Degenerative Mitral Regurgitation through a prospective, multicenter clinical trial using objective performance criteria.",[58,25],"Mitral Regurgitation","2024-06-04",{"date":61,"type":34},"2024-06-05",{"date":63,"type":34},"2022-11-24",{"date":65,"type":21},"2029-11-24",{"name":67,"class":68},"Peijia Medical Technology (Suzhou) Co., Ltd.","INDUSTRY",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":53,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":42},"100484989","effect-of-rt3d-tee-guided-mitral-valve-repair-on-outcomes-in-patients-with-degenerative-mitral-valve-disease-100484989","NCT05595226","Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease","TEEMR","Inclusion Criteria:\n\n* Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.\n* Informed consent was obtained\n\nExclusion Criteria:\n\n* Re-operation of mitral regurgitation\n* Concurrent surgical plan for congenital heart disease, coronary artery bypass grafting, aortic valve surgery, radiofrequency ablation of atrial fibrillation and other cardiac surgeries.\n* Mitral valve replacement\n* Unable to undergo TEE","80 Years",{"count":78,"type":21},338,[55],"The aim of this randomized controlled trial to investigate the effects of Real-time 3D transesophageal echocardiography (RT3D-TEE)-guided mitral valve repair on surgical failure and 1-year reoccurrence of mitral valve regurgitation in patients with degenerative mitral value disease.",[25],"2022-10-26",{"date":84,"type":34},"2022-10-28",{"date":86,"type":34},"2021-12-31",{"date":88,"type":21},"2026-12-31",{"name":90,"class":41},"Sheng Liu",{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":53,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":4},"100414672","explore-dmr-early-feasibility-study-of-the-plar-implant-and-delivery-system-to-treat-degenerative-mitral-regurgitation-100414672","NCT04679662","EXPLORE DMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation","Early Feasibility Study of the PLAR Implant and Delivery System to Treat Degenerative Mitral Regurgitation (EXPLORE DMR)","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Greater than moderate degenerative mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure\n3. Patient must present with an STS Score less than 10%\n4. High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure\n5. New York Heart Association (NYHA) Functional Class III or IV\n6. Patient willing to participate in study and provide signed IRB\u002FEC-approved informed consent\n7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n1. Severe tricuspid regurgitation\n2. Severe aortic stenosis or insufficiency\n3. Severe mitral annulus calcification\n4. Diseased mitral anterior leaflet such as flail \u002F prolapse\u002F heavy calcification\n5. Implanted vena cava filter\n6. Femoral veins with severe angulation and calcification\n7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan\n8. Active infection or endocarditis\n9. Previous mitral valve surgery\n10. Prior orthotopic heart transplantation\n11. Pulmonary artery systolic hypertension \\> 70mmHg\n12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus\n13. Left ventricular ejection fraction (LVEF) \\\u003C 30%\n14. Implant or revision of any pacing device \\\u003C 30 days prior to intervention\n15. Symptomatic coronary artery disease treated \\\u003C 30 days prior to study procedure\n16. Myocardial infarction requiring intervention \\\u003C 30 days prior to study procedure\n17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis\n18. Active peptic ulcer or upper gastrointestinal bleeding \\\u003C 90 days prior to study procedure\n19. Stroke \\\u003C 180 days prior to study procedure\n20. Severe renal insufficiency (creatinine \\> 3.0 mg\u002FdL) or patient requiring dialysis\n21. Cardiogenic shock at time of enrolment\n22. Hemodynamic instability requiring inotropic support or mechanical heart assistance\n23. Concurrent medical condition with a life expectancy of less than 2 years\n24. Pregnancy at time of enrolment\n25. History of bleeding diathesis or coagulopathy or leukopenia (WBC \\\u003C 3,000 mcL) or acute anemia (Hb \\\u003C 9 g\u002FdL) or thrombocytopenia (platelets \\\u003C 50,000 cells mcL)\n26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated\n27. Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial\u002Fprocedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments\n28. Emergency situations\n29. Company employees or their immediate family members\n30. Patient is under guardianship\n31. Patient is participating in another clinical study for which follow-up is currently ongoing",{"count":99,"type":21},10,[55],"An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe degenerative mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.",[25],"NOT_YET_RECRUITING","2020-12-21",{"date":106,"type":34},"2020-12-22",{"date":108,"type":21},"2021-03",{"date":110,"type":21},"2026-12",{"name":112,"class":68},"Polares Medical SA"]