[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai MicroPort CardioFlow Medtech Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":126},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,65,86,108],{"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":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100557249","vitaflow-liberty-europe-100557249","NCT06535659","VitaFlow LIBERTY Europe","VitaFlow Liberty™ Transcatheter Aortic Valve System Post-market Clinical Follow-up Study","Inclusion Criteria:\n\n1. Subjects of age≥ 18 years\n2. Subjects with severe, symptomatic, calcific aortic stenosis who are considered at high risk for surgical aortic valve replacement (AVR).\n3. Subject can understand the purpose of the clinical investigation, has signed voluntarily the informed consent form and is agreeing to the scheduled follow up requirements.\n\nExclusion Criteria:\n\n1. Pre-existing mechanical heart valve in aortic position\n2. A known hypersensitivity or contraindication to all anticoagulation \u002Fantiplatelet regimens (or inability to be anticoagulated for the index procedure), to nickel or titanium, to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media\n3. Ongoing sepsis, including active endocarditis\n4. Anatomically not suitable for the VitaFlow Liberty TAV system\n5. LVEF\\\u003C20%\n6. Estimated life expectancy of less than 12 months\n7. Any medical, social or psychological condition that in the opinion of the Heart Team precludes the subject from receiving transcatheter aortic valve replacement\n8. Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed\n9. Inability to comply with the clinical investigation follow-up or other clinical investigation requirements\n10. Patients temporally unable to provide written informed consent (e. g. unconscious emergency patients)","18 Years",{"count":49,"type":20},222,"OBSERVATIONAL","This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the routine practice for the treatment of severe aortic valve stenosis. The primary endpoint is the composite rate of all-cause mortality and stroke with disability at 12 months.\n\nPatients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.",[53],"Aortic Valve Stenosis",[55],"Transcatheter aortic valve replacement","RECRUITING",{"date":58,"type":31},"2026-10-01",{"date":60,"type":31},"2025-05-06",{"date":62,"type":20},"2033-06",{"name":37,"class":38},9,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100514343","vitaflow-transcatheter-aortic-valve-replacement-system-pre-market-trial-long-term-follow-up-vital-100514343","NCT05977257","VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）","VITAL","Inclusion Criteria:\n\n* Must meet 1, 2, 3, 4 or 1, 5 to be selected:\n\n  1. Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions\\*;\n  2. Be able to get in touch with the patient or his legal guardian\u002Frelative;\n  3. Patients who can understand the purpose and nature of the follow-up of this study, and are willing to cooperate with the follow-up and provide follow-up information;\n  4. Sign the informed consent form;\n  5. Patients who are known to have died.\n\n     * 4 research institutions: Zhongshan Hospital Fudan University, Second Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University and Fuwai Hospital.\n\nExclusion Criteria:\n\n1. Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint;\n2. The investigator judges that the patient's compliance is poor and the study cannot be completed as required.",{"count":73,"type":20},89,"This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.",[76,53],"Aortic Valve Disease","2023-07-28",{"date":79,"type":31},"2023-08-04",{"date":81,"type":20},"2023-07-30",{"date":83,"type":20},"2028-10-30",{"name":37,"class":38},4,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":21,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":85},"100394347","vitaflow-ii-transcatheter-aortic-valve-system-pre-market-trial-100394347","NCT04414878","VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial","A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis","Inclusion Criteria:\n\n1. Age≥70 years;\n2. Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m\u002Fs, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area\\\u003C0.8cm² (or EOA index\\\u003C0.5cm²\u002Fm²);\n3. NYHA≥II class;\n4. Estimated life-expectancy\\>12 months after implantation of the prosthetic valve;\n5. Anatomically suitable for the transcatheter aortic valve implantation procedure;\n6. The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.\n\nExclusion Criteria:\n\n1. Acute myocardial infarction (MI) in last 30 days before the treatment;\n2. Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；\n3. Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;\n4. Previous implantation of heart valve at any position；\n5. Hemodynamic instability requiring mechanical hemodynamic support devices;\n6. Need for emergency surgery for any reason;\n7. Hypertrophic cardiomyopathy with obstruction;\n8. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C 20%;Severe right ventricular dysfunction;\n9. Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;\n10. Known hypersensitivity or contraindication to all anticoagulation\u002Fantiplatelet regimens, to nitinol, contrast media or other relevant elements.\n11. Congenital aortic valve stenosis or unicuspid aortic valve;\n12. Vascular diseases or anatomical condition preventing the device access;\n13. Active endocarditis or other active infections at the time of treatment;\n14. Participating in another trial and the primary endpoint is not achieved.\n15. Inability to comply with the clinical investigation follow-up or other requirements.","70 Years",{"count":95,"type":20},145,[23],"This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.",[99],"Aortic Stenosis","2020-05-31",{"date":102,"type":31},"2020-06-04",{"date":104,"type":31},"2018-01-31",{"date":106,"type":20},"2027-01-31",{"name":37,"class":38},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100394346","vitaflow-transcatheter-aortic-valve-system-post-market-study-the-launch-study-100394346","NCT04414865","VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study","A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis","Inclusion Criteria:\n\n* Age≥70 years;\n* Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m\u002Fs, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area\\\u003C0.8cm² (or EOA index\\\u003C0.5cm²\u002Fm²);\n* The patients considered to be not suitable for surgical aortic valve replacement (SAVR);\n* The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.\n\nExclusion Criteria:\n\n* Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；\n* Vascular diseases or anatomical condition preventing the device access；\n* Previous implantation of mechanical or bioprosthesis valve in the aortic position；\n* Known hypersensitivity or contraindication to all anticoagulation\u002Fantiplatelet regimens, to nitinol, contrast media or other relevant elements；\n* Ongoing sepsis, including active endocarditis；\n* Estimated Life expectancy\\\u003C 12 months；\n* Participating in another trial and the primary endpoint is not achieved.\n* Inability to comply with the clinical investigation follow-up or other requirements.",{"count":116,"type":20},100,"The study objective is to evaluate safety and effectiveness\u002Fperformance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.",[53],{"date":102,"type":31},{"date":121,"type":31},"2020-04-26",{"date":123,"type":20},"2027-12-30",{"name":37,"class":38},2,""]