[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514343":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":65,"studyPopulation":66,"armGroups":67,"interventions":72,"overallOfficials":78,"centralContacts":83,"locations":89,"responsibleParty":137,"collaborators":61,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":61,"enrollmentInfo":148,"targetDuration":61,"studyType":151,"phases":61,"briefSummary":152,"conditions":153,"keywords":61,"overallStatus":156,"whyStopped":61,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Shanghai MicroPort CardioFlow Medtech Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":61},[9],{"measure":10,"description":11,"timeFrame":12},"All cause mortality","rate of all cause mortality","7years after the operation",[14,18,21,24,27,30,34,38,40,42,44,46,49,52,55,57,59],{"measure":15,"description":16,"timeFrame":17},"Cardiac death","rate of Cardiac death","6 years, 7 years, 8 years, 9 years and 10 years after the operation",{"measure":19,"description":20,"timeFrame":17},"Stroke","rate of stroke",{"measure":22,"description":23,"timeFrame":17},"valve-related rehospitalization","rate of valve-related rehospitalization",{"measure":25,"description":26,"timeFrame":17},"Serious Adverse Event","rate of Serious Adverse Event",{"measure":28,"description":29,"timeFrame":17},"Blood pressure","Systolic and Diastolic Blood Pressure",{"measure":31,"description":32,"timeFrame":33},"The 12-Item Short Form Health Survey (SF-12)","Scores range from 0 to 100, higher scores are better","6years, 7years, 8 years, 9 years and 10 years after the operation",{"measure":35,"description":36,"timeFrame":37},"Mean transvalvular pressure gradient","Transthoracic Echocardiogram test","7years,and 10 years after the operation",{"measure":39,"description":36,"timeFrame":37},"Effective orifice area",{"measure":41,"description":36,"timeFrame":37},"Peak velocity",{"measure":43,"description":36,"timeFrame":37},"class of Paravalvular leak",{"measure":45,"description":36,"timeFrame":37},"class of Aortic regurgitation",{"measure":47,"description":48,"timeFrame":37},"New York Heart Association Class for heart function","NYHA class",{"measure":50,"description":51,"timeFrame":37},"Kansas City Cardiomyopathy Questionnaire","Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better",{"measure":53,"description":54,"timeFrame":37},"Natriuretic peptide tests ( NT Pro-BNP or BNP)","blood test",{"measure":56,"description":36,"timeFrame":37},"moderate and severe structural valve deterioration SVD",{"measure":58,"description":36,"timeFrame":37},"bioprosthetic valve failure，BVF",{"measure":10,"description":11,"timeFrame":60},"6 years, 8 years, 9 years and 10 years after the operation",null,{"allocation":61,"interventionModel":61,"interventionModelDescription":61,"primaryPurpose":61,"observationalModel":63,"timePerspective":64,"maskingInfo":61},"COHORT","PROSPECTIVE","This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.","Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial",[68],{"label":69,"type":61,"description":69,"interventionNames":70},"Non Interventional long term safety follow up",[71],"Device: VitaFlow® Transcatheter Aortic Valve Replacement System",[73],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":61},"DEVICE","VitaFlow® Transcatheter Aortic Valve Replacement System","This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial",[69],[79],{"name":80,"affiliation":81,"role":82},"Daxin Zhou","Fudan University","PRINCIPAL_INVESTIGATOR",[84],{"name":85,"role":86,"phone":87,"phoneExt":61,"email":88},"JIATONG ZHANG","CONTACT","+8617797187661","JiaTong.Zhang@microport.com",[90,104,115,126],{"facility":91,"status":61,"city":92,"state":61,"zip":61,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Fuwai CVD Hospital of Chinese Academy of Medical Sciences","Beijing","China","CN",{"type":96,"coordinates":97},"Point",[98,99],116.39723,39.9075,{"lat":99,"lon":98},[102],{"name":103,"role":86,"phone":61,"phoneExt":61,"email":61},"Yongjian Wu",{"facility":105,"status":61,"city":106,"state":61,"zip":61,"country":93,"countryCode":94,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"West China Hospital, Sichuan University","Chengdu",{"type":96,"coordinates":108},[109,110],104.06667,30.66667,{"lat":110,"lon":109},[113],{"name":114,"role":86,"phone":61,"phoneExt":61,"email":61},"Yuan Feng",{"facility":116,"status":61,"city":117,"state":61,"zip":61,"country":93,"countryCode":94,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"The Second Affiliated Hospital Zhejiang University School of Medicine","Hangzhou",{"type":96,"coordinates":119},[120,121],120.16142,30.29365,{"lat":121,"lon":120},[124],{"name":125,"role":86,"phone":61,"phoneExt":61,"email":61},"Jianan Wang",{"facility":127,"status":61,"city":128,"state":61,"zip":61,"country":93,"countryCode":94,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Zhongshan Hospital Fudan University","Shanghai",{"type":96,"coordinates":130},[131,132],121.45806,31.22222,{"lat":132,"lon":131},[135,136],{"name":80,"role":86,"phone":61,"phoneExt":61,"email":61},{"name":80,"role":82,"phone":61,"phoneExt":61,"email":61},{"type":138,"investigatorFullName":61,"investigatorTitle":61,"investigatorAffiliation":61,"oldNameTitle":61,"oldOrganization":61},"SPONSOR","100514343","vitaflow-transcatheter-aortic-valve-replacement-system-pre-market-trial-long-term-follow-up-vital-100514343",false,"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.","ALL","18 Years",{"count":149,"type":150},89,"ESTIMATED","OBSERVATIONAL","This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.",[154,155],"Aortic Valve Disease","Aortic Valve Stenosis","NOT_YET_RECRUITING","2023-07-28",{"date":159,"type":160},"2023-08-04","ACTUAL",{"date":162,"type":150},"2023-07-30",{"date":164,"type":150},"2028-10-30",{"name":5,"class":6},4]