[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578960":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":103,"collaborators":26,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":26,"enrollmentInfo":116,"targetDuration":26,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VitaFlow","EXPERIMENTAL","Patients who meet the inclusion and exclusion criteria will undergo TAVR using the VitaFlow™ self-expanding valve system.",[13],"Combination Product: VitaFlow+GDMT",{"label":15,"type":16,"description":17,"interventionNames":18},"J-Valve","ACTIVE_COMPARATOR","Patients who meet the inclusion and exclusion criteria will undergo TF-TAVR using dedicated transcatheter device J-Valve system.",[19],"Combination Product: J-Valve+GDMT",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","VitaFlow+GDMT","The patient will undergo transcatheter aortic valve replacement on the basis of guideline-directed medical therapy with The VitaFlow™ system.\n\nThe VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"J-Valve+GDMT","The patient will undergo transfemoral aortic valve replacement on the basis of guideline-directed medical therapy with The J-Valve system (Jie ChengMedical Technologies, Suzhou, China). The J-Valve system is a second-generation self-expand able device composed of a porcine bioprosthetic aortic valve and a transfemoral delivery sheath. The valve is supported by a self-expanding nitinol structure. The different valve sizes are 21, 23, 25, 27, 29 and 34 mm. Three U-shaped nitinol graspers were designed to surround the valve.",[15],[32],{"name":33,"affiliation":5,"role":34},"ZhengBin Zhu, MD. PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Zhengbin Zhu, MD. PhD.","CONTACT","0086-15601950612","zzb11561@rjh.com.cn",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Jiwei Yu, MD","0086-13761292857","yjw12506@rjh.com.cn",[46,65,78,90],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Ruijin hospital, Shanghai JiaoTong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":55,"coordinates":56},"Point",[57,58],121.45806,31.22222,{"lat":58,"lon":57},[61,63],{"name":42,"role":38,"phone":62,"phoneExt":26,"email":44},"86-021-64370045",{"name":64,"role":34,"phone":26,"phoneExt":26,"email":26},"ZhengBin Zhu, MD,PHD",{"facility":66,"status":48,"city":49,"state":50,"zip":67,"country":52,"countryCode":53,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Shanghai Chest Hospital","200030",{"type":55,"coordinates":69},[57,58],{"lat":58,"lon":57},[72,76],{"name":73,"role":38,"phone":74,"phoneExt":26,"email":75},"Yanjie Li, MD,PHD","86-021-22200000","liyanjie6666@126.com",{"name":77,"role":34,"phone":26,"phoneExt":26,"email":26},"Xin Pan, MD",{"facility":79,"status":48,"city":49,"state":50,"zip":80,"country":52,"countryCode":53,"cosmosGeoPoint":81,"geoPoint":83,"contacts":84},"Zhongshan Hospital, Fudan University","200032",{"type":55,"coordinates":82},[57,58],{"lat":58,"lon":57},[85,89],{"name":86,"role":38,"phone":87,"phoneExt":26,"email":88},"Li Zhu, Deputy Chief Nurse","86-021-64041990","zhu.li@zs-hospital.sh.cn",{"name":86,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":91,"status":48,"city":49,"state":50,"zip":92,"country":52,"countryCode":53,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"Changhai Hospital","200433",{"type":55,"coordinates":94},[57,58],{"lat":58,"lon":57},[97,101],{"name":98,"role":38,"phone":99,"phoneExt":26,"email":100},"Zhu Ni, MD,PHD","86-021-31166666","nizhu@outlook.com",{"name":102,"role":34,"phone":26,"phoneExt":26,"email":26},"Ni Zhu, MD,PHD",{"type":34,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Zhu zhengbin","Principal Investigator","100578960","phase-4-transcatheter-treatment-of-pure-aortic-regurgitation-with-vitaflow-liberty-system-100578960",false,"NCT06818084","TRanscAtheter TreatMent of PurE Aortic Regurgitation With VitaFlow Liberty System","Transcatheter Treatment of Pure Aortic Regurgitation With VitaFlow Liberty System: a Prospective, Multicenter Study","TRAMPERS","Inclusion Criteria Age ≥ 60 years. Symptomatic moderate-to-severe or greater isolated aortic regurgitation.\n\nAsymptomatic moderate-to-severe or greater isolated aortic regurgitation meeting at least one of the following criteria:\n\nLVEF ≤ 55% (measured by biplane Simpson's method); LVESD \\> 50 mm ; LVESDi \\> 22 mm\u002Fmm²； LVESVi \\> 45mL\u002Fm2 Anatomical suitability for TAVR as assessed by the heart team. Provision of written informed consent by the patient or their legal guardian, with agreement to the treatment plan and willingness and ability to comply with all required follow-up assessments.\n\nExclusion Criteria Incomplete coronary revascularization. Less than 30 days of guideline-directed medical therapy at maximally tolerated doses.\n\nLife expectancy \\\u003C 1 year. LVEF \\\u003C 45%. eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m². Known allergy or contraindication to required medications (e.g., aspirin, clopidogrel, warfarin) or contrast media.\n\nAny condition that precludes contrast-enhanced CT. Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation.\n\nPoor patient compliance, unable to complete follow-up as required. Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.","ALL","60 Years",{"count":117,"type":118},120,"ESTIMATED","INTERVENTIONAL",[121],"PHASE4","This study is a prospective, multicenter, non-randomized controlled trial, planning to enroll 180 patients with pure native aortic regurgitation. On the basis of standardized medical therapy, patients will be assigned in a 1:1 ratio to undergo transfemoral transcatheter aortic valve replacement (TF-TAVR) . This prospective, multicenter trial aims to evaluate the safety and effectiveness of transfemoral TAVR using the VitaFlow™ self-expanding valve system compared to dedicated transcatheter devices in patients with PNAR.\n\nThe primary endpoint is a composite of all-cause mortality, disabling stroke, and rehospitalization for heart failure, myocardial Infarction, and requiring dialysis or valve reoperation at 12 months post-procedure.\n\nSecondary endpoints include procedure-related complications, long-term clinical events, patient functional status and quality of life, bioprosthetic valve imaging follow-up, echocardiographic parameters, and treatment costs. All endpoint definitions conform to the Valve Academic Research Consortium-3 (VARC-3) criteria",[124,125,126],"AORTIC VALVE DISEASES","Aortic Regurgitation","Transcatheter Aortic Valve Replacement (TAVR)",[128,129,130,131],"pure aortic regurgitation","Transcatheter aortic valve replacement (TAVR)","hypoattenuated leaflet thickening","reduced leaflet motion","2026-01-27",{"date":134,"type":135},"2026-01-30","ACTUAL",{"date":137,"type":135},"2025-04-29",{"date":139,"type":118},"2027-11-30",{"name":5,"class":6},4]