[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"degenerative-mitral-regurgitation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:degenerative-mitral-regurgitation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100659001","cardioflow-transcatheter-mitral-valve-replacement-system-pre-market-clinical-investigation-100659001",false,"NCT07857343","CardioFlow Transcatheter Mitral Valve Replacement System Pre-market Clinical Investigation","A Prospective, Multicenter, Single-arm Clinical Investigation for the Evaluation of Safety and Effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement System in the Treatment of Moderate to Severe or Severe Symptomatic Mitral Regurgitation(CF-TMVR)","Subjects must meet all of the following criteria to be included in the study:\n\n* Subject has symptomatic, moderate-to-severe or severe, degenerative mitral regurgitation(MR≥3+);\n* NYHA functional class≥ II;\n* Heart team agrees that patient is unsuitable for treatment with conventional mitral valve surgery or transcatheter mitral valve edge-to-edge repair；\n* Subjects age ≥65 years old;\n* Subjects willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits;\n* Subjects anatomically suitable for the transcatheter mitral valve implantation\n\nSubjects will be excluded from the study if any of the following conditions are present：\n\n* Left ventricular ejection fraction (LVEF)\\\u003C30%；\n* Left ventricular end diastolic diameter (LVEDD)\\>7.5cm；\n* Cardiac echography evidence of intracardiac mass, thrombus, or vegetation；\n* Severe tricuspid regurgitation with severe right ventricular dysfunction or any tricuspid valve disease requiring surgery or transcatheter intervention；\n* Aortic valve diseases requiring surgery or transcatheter intervention；\n* Any prohibitive mitral annular calcification(annulus to the leaflet) interferes the expansion of the device；\n* Prior surgical treatment of mitral valve；\n* Therapeutic cardiac surgical or interventional procedure within 30 days prior to the index procedure；\n* End-stage heart failure requiring left ventricular assist device or cardiac transplantation\n* Subjects with severe major vascular disease requiring surgical intervention or with aortic dissection\n* Need for emergent surgery\n* Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis\n* Mitral valve pathological anatomy，LVOT anatomy, left atrial or ventricle anatomy not applicable for the investigational device implantation；\n* Concurrent medical condition with a life expectancy of less than 12 months\n* Evidence of an acute myocardial infarction or untreated clinically significant coronary artery disease requiring revascularization within 30 days of enrollment.\n* Recent cerebrovascular events(ischemic or hemorrhage stroke, not including TIA) within 3 months of enrollment\n* Severe carotid stenosis( \\> 70%, both sides of carotid artery)\n* Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated；\n* Active endocarditis or active other infection\n* Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months\n* Subject refuses the blood transfusion;\n* Known hypersensitivity or contraindication to nitinol (titanium or nickel),bovine product, PET(Polyethylene terephthalate), contrast media; Inability to tolerate anti-platelet or anticoagulants therapy; Contraindicated for transesophageal echocardiography (TEE)\n* Condition that prevents transapical access, such as chest malformation, ventricular aneurysm, apical thinning\n* Subjects with rheumatic mitral stenosis\n* Acute exacerbation of chronic obstructive pulmonary disease\n* Per heart team assessment, conditions that not suitable for transcatheter mitral valve replacement\n* Severe disabling Alzheimer's disease\n* Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint","ALL","65 Years",{"count":19,"type":20},152,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a prospective, multi-center, single-arm study to assess the safety and effectiveness of Microport CardioFlow Transcatheter Mitral Valve Replacement system in the treatment of moderate to severe or severe degenerative mitral regurgitation and to provide the clinical evidence for product registration in China or other countries",[26],"Degenerative Mitral Regurgitation","NOT_YET_RECRUITING","2026-09-28",{"date":30,"type":31},"2026-10-05","ACTUAL",{"date":33,"type":20},"2026-12-01",{"date":35,"type":20},"2035-01-01",{"name":37,"class":38},"Shanghai MicroPort CardioFlow Medtech Co., Ltd.","INDUSTRY",3,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100629141","fih-ita-study---vesalius-tmvr-system-for-symptomatic-degenerative-mitral-regurgitation-100629141","NCT07470788","FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation","A First-in-Human Investigational Testing Authorization Study Evaluating the Safety and Performance of the Vesalius Transcatheter Mitral Valve Repair System in Patients With Severe, Symptomatic Degenerative Mitral Regurgitation","Inclusion Criteria:\n\n1. Age ≥ 19 years\n2. Moderate to severe (≥3+) or severe (≥4+) degenerative mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines, depicted in Figure 14)\n3. New York Heart Association (NYHA) Functional Class II, III, or Ambulatory (IV)\n4. Elevated risk for surgical mitral valve repair: Society of Thoracic Surgery (STS) predicted risk of mortality (PROM) of ≥6% as determined by the STS Risk Calculator for Surgical Repair of Primary Mitral Regurgitation \\[1\\], as well as patient operative risk assessment by the Heart Team\n5. Suitable anatomy for the Vesalius TMVr System as determined by pre-procedure imaging\n6. Willing to adhere to study follow-up schedule for up to 5 years\n7. Written informed consent provided\n\nExclusion Criteria:\n\n1. Anatomy ideally suitable for other approved transcatheter therapy (i.e. TEER candidate)\n2. LV ejection fraction \\\u003C 30%\n3. Active bacterial endocarditis within 60 days of planned index procedure\n4. Dialysis-dependent renal insufficiency\n5. Body Mass Index (BMI) ≥ 45 kg\u002Fm2\n6. Previous valvular surgery\n7. Previous atrial septal surgery\n8. Previous endovascular structural procedure(s) and\u002For device(s) within 6 months\n9. Severe mitral annular calcification (MAC) prohibiting device implantation\n10. Severe annulus or leaflet calcification\n11. Leaflet perforation\n12. Contraindication to anticoagulation \u002F antiplatelet therapy\n13. Patients with sensitivity to nickel or contrast media\n14. Concomitant severe tricuspid regurgitation\n15. Absence of conventional medial and lateral papillary muscle groups\n16. Femoral vein cannot accommodate a 29 F catheter\n17. Contraindication to Transoesophageal echocardiography (TEE)\n18. Life expectancy \\\u003C1 year due to non-cardiac comorbidities.\n19. Presence of other anatomic, comorbid conditions, or other medical conditions that could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results, in the opinion of the Heart Team\n20. Participation in other clinical investigation\n21. Pregnant or planning to become pregnant","19 Years",{"count":49,"type":20},5,[23],"This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation. The study will enroll patients who are at high or prohibitive risk for conventional surgical repair or replacement of the mitral valve. Participants will receive implantation of the Vesalius TMVr System and will be followed to assess clinical outcomes, device performance, and any adverse events.",[26],"RECRUITING","2026-08-17",{"date":56,"type":31},"2026-08-19",{"date":58,"type":20},"2026-08",{"date":60,"type":20},"2032-04",{"name":62,"class":38},"Vesalius Cardiovascular Inc.",1]