[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100394346":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":48,"studyPopulation":49,"armGroups":50,"interventions":56,"overallOfficials":44,"centralContacts":62,"locations":71,"responsibleParty":101,"collaborators":44,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":44,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":44,"enrollmentInfo":112,"targetDuration":44,"studyType":115,"phases":44,"briefSummary":116,"conditions":117,"keywords":44,"overallStatus":92,"whyStopped":44,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Shanghai MicroPort CardioFlow Medtech Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[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",[14,18,21,24,28,31,35,38,41],{"measure":15,"description":16,"timeFrame":17},"Valve function-mean transvalvular gradient","Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg)","at discharge, 30 days, 1 year and annually up to 5 years 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, new permanent pacemaker implantation","at immediate, 30 days, 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, TAV-in-TAV, valve related dysfunction requiring repeat procedure (TAVI,SAVR,BAV)",{"measure":32,"description":33,"timeFrame":34},"Rate of device success","Rate of device success, assessed by the access, delivery, deployment and implantation of the device and the prosthetic valve function","at immediate post implantation",{"measure":36,"description":37,"timeFrame":34},"Rate of balloon pre-dilatation success","Rate of balloon pre-dilatation success, assessed by the access, delivery, pre-dilatation and retrieval of the balloon catheter",{"measure":39,"description":40,"timeFrame":34},"Rate of balloon post-dilatation success","Rate of balloon pre-dilatation success, assessed by the access, delivery, post-dilatation and retrieval of the balloon catheter",{"measure":42,"description":43,"timeFrame":34},"Rate of procedure success","Rate of procedure success, assessed by the device success and peri-procedural complications",null,{"allocation":44,"interventionModel":44,"interventionModelDescription":44,"primaryPurpose":44,"observationalModel":46,"timePerspective":47,"maskingInfo":44},"COHORT","PROSPECTIVE","This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™ Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.","The study population includes symptomatic patients (≥70 years old ) with calcified, severe, degenerative, native aortic valve stenosis who are not suitable for the surgical aortic valve replacement as assessed by the heart team",[51],{"label":52,"type":44,"description":53,"interventionNames":54},"single arm, treatment group","Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System",[55],"Device: VitaFlow™ Transcatheter Aortic Valve System",[57],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":44},"DEVICE","VitaFlow™ Transcatheter Aortic Valve System","VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set",[52],[63,68],{"name":64,"role":65,"phone":66,"phoneExt":44,"email":67},"Zhujun Cai, PhD","CONTACT","(86)(21)38954600","zjcai@micoport.com",{"name":69,"role":65,"phone":66,"phoneExt":44,"email":70},"Jie Bi","jbi@micoport.com",[72,90],{"facility":73,"status":74,"city":75,"state":76,"zip":44,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Ruijing Hospital，Jiaotong University School of Medicine","NOT_YET_RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":80,"coordinates":81},"Point",[82,83],121.45806,31.22222,{"lat":83,"lon":82},[86],{"name":87,"role":65,"phone":88,"phoneExt":44,"email":89},"Ruiyan Zhang, Prof","13601911729","zhangruiyan@263.net",{"facility":91,"status":92,"city":75,"state":76,"zip":44,"country":77,"countryCode":78,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"Zhongshan Hospital","RECRUITING",{"type":80,"coordinates":94},[82,83],{"lat":83,"lon":82},[97],{"name":98,"role":65,"phone":99,"phoneExt":44,"email":100},"Daxin Zhou, Prof","13801641512","zhou.daxin@zs-hospital.sh.cn",{"type":102,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100394346","vitaflow-transcatheter-aortic-valve-system-post-market-study-the-launch-study-100394346",false,"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.","ALL","70 Years",{"count":113,"type":114},100,"ESTIMATED","OBSERVATIONAL","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.",[118],"Aortic Valve Stenosis","2020-05-31",{"date":121,"type":122},"2020-06-04","ACTUAL",{"date":124,"type":122},"2020-04-26",{"date":126,"type":114},"2027-12-30",{"name":5,"class":6},2]