[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100394347":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":54,"studyPopulation":47,"armGroups":55,"interventions":62,"overallOfficials":47,"centralContacts":68,"locations":77,"responsibleParty":134,"collaborators":47,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":47,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":47,"enrollmentInfo":145,"targetDuration":47,"studyType":148,"phases":149,"briefSummary":150,"conditions":151,"keywords":47,"overallStatus":80,"whyStopped":47,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Shanghai MicroPort CardioFlow Medtech Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of all-cause mortality at 12 months post implantation","Rate of all-cause mortality including cardiovascular and non-cardiovascular death","12 months post implantation",[14,18,21,24,28,31,34,38,41,44],{"measure":15,"description":16,"timeFrame":17},"Valve function-mean prosthetic valve gradient","Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)","at 30 days, 6 months, and 1 year post implantation",{"measure":19,"description":20,"timeFrame":17},"Valve function- effective orifice area","Effective orifice area measured by transthoracic echocardiography (TTE)(in cm\\^2)",{"measure":22,"description":23,"timeFrame":17},"Valve function- degree of prosthetic valve regurgitation","Degree of prosthetic valve regurgitation including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)",{"measure":25,"description":26,"timeFrame":27},"Rate of safety events according to VARC2","Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, conduction disturbance and arrhythmias, and new permanent pacemaker implantation","at 30 days, 6 months, 1 year and annually up to 5 years post implantation",{"measure":29,"description":30,"timeFrame":27},"Rate of other TAVI-related complications","Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, and TAV-in-TAV",{"measure":32,"description":33,"timeFrame":27},"Rate of major adverse cardiac and cerebrovascular events(MACCE)","Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances",{"measure":35,"description":36,"timeFrame":37},"Rate of device success","Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function","at immediate post implantation",{"measure":39,"description":40,"timeFrame":37},"Rate of balloon pre-dilation success","Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter",{"measure":42,"description":43,"timeFrame":37},"Rate of balloon post-dilation success","Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter",{"measure":45,"description":46,"timeFrame":37},"Rate of procedure success","Rate of procedure success, assessed by the device success and the peri-procedural complications",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"NA","SINGLE_GROUP","TREATMENT",{"masking":53,"maskingDescription":47,"whoMasked":47},"NONE","This a prospective, multi-center, single-arm, objective performance 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. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.",[56],{"label":57,"type":58,"description":59,"interventionNames":60},"Single arm clinical investigation","EXPERIMENTAL","Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System",[61],"Device: VitaFlow™ II Transcatheter Aortic Valve System",[63],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":47},"DEVICE","VitaFlow™ II Transcatheter Aortic Valve System","VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire",[57],[69,74],{"name":70,"role":71,"phone":72,"phoneExt":47,"email":73},"Bi Jie","CONTACT","(86)(21)38954600","jbi@microport.com",{"name":75,"role":71,"phone":72,"phoneExt":47,"email":76},"Zhujun Cai, PhD","zjcai@microport.com",[78,95,108,121],{"facility":79,"status":80,"city":81,"state":82,"zip":47,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Fuwai Hospital","RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":86,"coordinates":87},"Point",[88,89],116.39723,39.9075,{"lat":89,"lon":88},[92],{"name":93,"role":71,"phone":94,"phoneExt":47,"email":47},"Yongjian Wu, Prof","13701387189",{"facility":96,"status":80,"city":97,"state":98,"zip":47,"country":83,"countryCode":84,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Zhongshan Hospital","Shanghai","Shanghai Municipality",{"type":86,"coordinates":100},[101,102],121.45806,31.22222,{"lat":102,"lon":101},[105],{"name":106,"role":71,"phone":107,"phoneExt":47,"email":47},"Junbo Ge, Prof","13901977506",{"facility":109,"status":80,"city":110,"state":111,"zip":47,"country":83,"countryCode":84,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"West China Hospital of Sichuan University","Chengdu","Sichuan",{"type":86,"coordinates":113},[114,115],104.06667,30.66667,{"lat":115,"lon":114},[118],{"name":119,"role":71,"phone":120,"phoneExt":47,"email":47},"Mao Chen, Prof","18980602046",{"facility":122,"status":80,"city":123,"state":124,"zip":47,"country":83,"countryCode":84,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"The Second Affiliated Hospital Zhejiang University School of Medicine","Hangzhou","Zhejiang",{"type":86,"coordinates":126},[127,128],120.16142,30.29365,{"lat":128,"lon":127},[131],{"name":132,"role":71,"phone":133,"phoneExt":47,"email":47},"Jian-An Wang, Prof","13805786328",{"type":135,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100394347","vitaflow-ii-transcatheter-aortic-valve-system-pre-market-trial-100394347",false,"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.","ALL","70 Years",{"count":146,"type":147},145,"ESTIMATED","INTERVENTIONAL",[49],"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.",[152],"Aortic Stenosis","2020-05-31",{"date":155,"type":156},"2020-06-04","ACTUAL",{"date":158,"type":156},"2018-01-31",{"date":160,"type":147},"2027-01-31",{"name":5,"class":6},4]