[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659001":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":11,"studyPopulation":11,"armGroups":67,"interventions":74,"overallOfficials":11,"centralContacts":11,"locations":80,"responsibleParty":122,"collaborators":11,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":11,"eligibilityCriteria":130,"healthyVolunteers":126,"sex":131,"minAge":132,"maxAge":11,"enrollmentInfo":133,"targetDuration":11,"studyType":136,"phases":137,"briefSummary":138,"conditions":139,"keywords":11,"overallStatus":141,"whyStopped":11,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Shanghai MicroPort CardioFlow Medtech Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of cumulative all-cause mortality at 12 months post-procedure",null,"12 months",[14,17,19,22,24,26,28,30,32,34,36,39,42,45,49,51,53,55,57,59],{"measure":15,"description":11,"timeFrame":16},"Rate of cumulative all-cause mortality at 30 days, 6 months and 2-5 years post procedure","30 days, 6 months and 2-5 years post procedure",{"measure":18,"description":11,"timeFrame":16},"Rate of heart failure rehospitalization at 30 days, 6 months and 2-5 years post procedure",{"measure":20,"description":11,"timeFrame":21},"Rate of disabling and non-disabling stroke at 30 days, 6 months, 12 months and 2-5 years post procedure","30 days, 6 months, 12 months and 2-5 years post procedure",{"measure":23,"description":11,"timeFrame":21},"Rate of myocardial infarction at 30 days, 6 months, 12 months and 2-5 years post procedure",{"measure":25,"description":11,"timeFrame":16},"Rate of major assess site and vascular complications at 30 days, 6 months and 2-5 years post procedure",{"measure":27,"description":11,"timeFrame":21},"Rate of major and above bleeding defined by MVARC at 30 days, 6 months, 12 months and 2-5 years post procedure",{"measure":29,"description":11,"timeFrame":21},"Rate of acute kidney injury (stage 2\u002F3) at 30 days, 6 months, 12 months and 2-5 years post procedure",{"measure":31,"description":11,"timeFrame":21},"Rate of arrhythmias and conduction system disturbances at 30 days, 6 months, 12 months and 2-5 years post procedure",{"measure":33,"description":11,"timeFrame":21},"Rate of permanent pacemaker implantation at 30 days, 6 months, 12 months and 2-5 years post procedure",{"measure":35,"description":11,"timeFrame":16},"Rate of mitral valve reoperation at 30 days, 6 months and 2-5 years post procedure",{"measure":37,"description":11,"timeFrame":38},"Technical success rate defined by MVARC at immediate post procedure","immediate post procedure",{"measure":40,"description":11,"timeFrame":41},"Device success rate defined by MVARC at 30 days post procedure","30 days post procedure",{"measure":43,"description":11,"timeFrame":44},"Procedural success rate defined by MVARC at 30 days","30 days",{"measure":46,"description":47,"timeFrame":48},"Bioprosthesis haemodynamic function","Mitral regurgitation (paravalvular leak and intra-valvular regurgitation)","30 days, 6 months, 12 months and 2-5 years",{"measure":46,"description":50,"timeFrame":48},"Mitral valve area",{"measure":46,"description":52,"timeFrame":48},"Mitral valve transvalvular pressure gradient",{"measure":54,"description":11,"timeFrame":21},"Change in NYHA classification at 30 days, 6 months, 12 months and 2-5 years post procedure",{"measure":56,"description":11,"timeFrame":48},"Change in QoL score from baseline at 30 days, 6 months, 12 months and 2-5 years as assessed by KCCQ",{"measure":58,"description":11,"timeFrame":48},"Change in 6 minute walk test at 30 days, 6 months, 12 months and 2-5 years",{"measure":60,"description":11,"timeFrame":21},"Rate of device-related technical failure issues and complications defined by MVARC at 30 days, 6 months, 12 months and 2-5 years post procedure",{"allocation":62,"interventionModel":63,"interventionModelDescription":11,"primaryPurpose":64,"observationalModel":11,"timePerspective":11,"maskingInfo":65},"NA","SINGLE_GROUP","TREATMENT",{"masking":66,"maskingDescription":11,"whoMasked":11},"NONE",[68],{"label":69,"type":70,"description":71,"interventionNames":72},"MicroPort CardioFlow Transcatheter Mitral Valve Replacement","EXPERIMENTAL","Subjects with moderate to severe or severe degenerative mitral regurgitation will undergo transcatheter mitral valve replacement",[73],"Device: Microport CardioFlow Mitral Valve Replacement System",[75],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":11},"DEVICE","Microport CardioFlow Mitral Valve Replacement System","Patients will undergo transcatheter mitral valve replacement using Microport CardioFlow Mitral Valve Replacement System. The device is delivered via a transapical approach under the guidance of medical imaging equipment; the valve product loaded within the delivery system is advanced to the mitral annulus and released, thereby replacing the native mitral valve with pathological changes in function or anatomy.",[69],[81,98,110],{"facility":82,"status":11,"city":83,"state":11,"zip":11,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Cardiology","Beijing","China","CN",{"type":87,"coordinates":88},"Point",[89,90],116.39723,39.9075,{"lat":90,"lon":89},[93],{"name":94,"role":95,"phone":96,"phoneExt":11,"email":97},"Xiangbin Pan","CONTACT","010-88398395","Xiangbin428@hotmail.com",{"facility":82,"status":11,"city":99,"state":11,"zip":11,"country":84,"countryCode":85,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Kunming",{"type":87,"coordinates":101},[102,103],102.71833,25.03889,{"lat":103,"lon":102},[106],{"name":107,"role":95,"phone":108,"phoneExt":11,"email":109},"Cheng Wang","0871-65199505","zdwangcheng@outlook.com",{"facility":82,"status":11,"city":111,"state":11,"zip":11,"country":84,"countryCode":85,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Zhengzhou",{"type":87,"coordinates":113},[114,115],113.64861,34.75778,{"lat":115,"lon":114},[118],{"name":119,"role":95,"phone":120,"phoneExt":11,"email":121},"Yiqiang Yuan","0371-58680176","zzqyyuanyiqiang@126.com",{"type":123,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":134,"type":135},152,"ESTIMATED","INTERVENTIONAL",[62],"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",[140],"Degenerative Mitral Regurgitation","NOT_YET_RECRUITING","2026-09-28",{"date":144,"type":145},"2026-10-05","ACTUAL",{"date":147,"type":135},"2026-12-01",{"date":149,"type":135},"2035-01-01",{"name":5,"class":6},3]