[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557249":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":56,"studyPopulation":65,"armGroups":66,"interventions":71,"overallOfficials":77,"centralContacts":82,"locations":92,"responsibleParty":218,"collaborators":56,"id":220,"slug":221,"hasResults":222,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":56,"eligibilityCriteria":226,"healthyVolunteers":222,"sex":227,"minAge":228,"maxAge":56,"enrollmentInfo":229,"targetDuration":56,"studyType":232,"phases":56,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":94,"whyStopped":56,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},{"fullName":5,"class":6},"Shanghai MicroPort CardioFlow Medtech Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":56},[9],{"measure":10,"description":10,"timeFrame":11},"Composite rate of all-cause mortality and stroke with disability","12 months post procedure",[13,17,20,23,27,30,34,36,38,42,44,46,50,54,58],{"measure":14,"description":15,"timeFrame":16},"Safety outcomes defined by VARC3","Rate of all-cause mortality, myocardial infarction, stroke, implanted related new and\u002For worsen conduction disturbances and arrhythmias, new permanent pacemaker implantation, procedure-related or valve-related hospitalization defined by VARC 3.","30 days, 12 months, and 2-5 years post procedure",{"measure":14,"description":18,"timeFrame":19},"Rate of type 2-4 bleeding, major vascular and access-related complications, acute kidney injury (stage 2-4) defined by VARC 3","30 days and 12 months post procedure",{"measure":14,"description":21,"timeFrame":22},"Rate of other acute procedural and technical valve related complications: conversion to surgery; unplanned use of mechanical circulatory support; implantation of multiple (\\>1) transcatheter valves during the index hospitalization; valve mal-position","acute procedure (within 24 hours)",{"measure":24,"description":25,"timeFrame":26},"Device success","Device success defined by VARC 3","30 days post implantation",{"measure":28,"description":29,"timeFrame":26},"Device early safety","Device early safety defined by VARC 3",{"measure":31,"description":32,"timeFrame":33},"Bioprosthesis haemodynamic function","Bioprosthesis haemodynamic function (assessed by echocardiography) including effective orifice area (cm2).","Discharge (24 hours to 7 days), 30 days,12 months and 2-5 years post implantation",{"measure":31,"description":35,"timeFrame":33},"Bioprosthesis haemodynamic function (assessed by echocardiography) including mean transvalvular gradient (mmHg).",{"measure":31,"description":37,"timeFrame":33},"Bioprosthesis haemodynamic function (assessed by echocardiography) including aortic regurgitation (paravalvular, central and total).",{"measure":39,"description":40,"timeFrame":41},"Bioprosthetic valve dysfunction","Moderate or severe haemodynamic valve deterioration defined by VARC3","12 months and 2-5 years post procedure",{"measure":39,"description":43,"timeFrame":41},"Bioprosthetic valve failure defined by VARC3",{"measure":39,"description":45,"timeFrame":41},"Clinically significant valve thrombosis defined by VARC3",{"measure":47,"description":48,"timeFrame":49},"NYHA Classification","Changes in cardiac function at discharge, 30 days and 12 months and 2-5 years post implantation according to the NYHA Classification Scheme compared to baseline","From baseline to discharge (24 hours to 7 days), 30 days, 12 months and 2-5 years post procedure",{"measure":51,"description":52,"timeFrame":53},"Rate of Alwide Plus Balloon Catheter pre-dilation success","Defined as successful access, delivery and dilation the aortic valve, and retrieval for the AlwideTM Plus balloon catheter","During procedure",{"measure":55,"description":56,"timeFrame":57},"Alwide Plus Balloon Catheter related adverse-event",null,"Discharge",{"measure":59,"description":60,"timeFrame":61},"Predictors for the permanent pacemaker implantation","Including but not limited to pre-existing conduction disturbance, implant depth, LVOT calcium volume , post-dilatation","Baseline or intraprocedure",{"allocation":56,"interventionModel":56,"interventionModelDescription":56,"primaryPurpose":56,"observationalModel":63,"timePerspective":64,"maskingInfo":56},"COHORT","PROSPECTIVE","Patients with symptomatic, severe calcified aortic stenosis who are at high surgical risk.",[67],{"label":68,"type":56,"description":56,"interventionNames":69},"Single arm clinical investigation",[70],"Device: VitaFlow Liberty™ Transcatheter Aortic Valve System",[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":56},"DEVICE","VitaFlow Liberty™ Transcatheter Aortic Valve System","Transcatheter Aortic Valve Replacement with VitaFlow Liberty™ Transcatheter Aortic Valve System.\n\nPatients will receive transcatheter aortic valve replacement and examinations at the screening, procedure, discharge, and follow-up per local standard of care.",[68],[78],{"name":79,"affiliation":80,"role":81},"Darren Mylotte, MD","Galway University Hospital","PRINCIPAL_INVESTIGATOR",[83,88],{"name":84,"role":85,"phone":86,"phoneExt":56,"email":87},"Yann Poezevara, PhD","CONTACT","0033-146013409","Yann.Poezevara@cf.microport.com",{"name":89,"role":85,"phone":90,"phoneExt":56,"email":91},"Zhujun Cai, PhD","86-021-38954600","zjcai@microport.com",[93,106,121,134,147,162,177,190,203],{"facility":80,"status":94,"city":95,"state":56,"zip":56,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"RECRUITING","Galway","Ireland","IE",{"type":99,"coordinates":100},"Point",[101,102],-9.05095,53.27245,{"lat":102,"lon":101},[105],{"name":79,"role":85,"phone":56,"phoneExt":56,"email":56},{"facility":107,"status":94,"city":108,"state":56,"zip":56,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Pineta Grande Hospital","Castel Volturno","Italy","IT",{"type":99,"coordinates":112},[113,114],13.94354,41.03288,{"lat":114,"lon":113},[117],{"name":118,"role":85,"phone":119,"phoneExt":56,"email":120},"Alberto Morello","+393397904191","albertomorello83@gmail.com",{"facility":122,"status":94,"city":123,"state":56,"zip":56,"country":109,"countryCode":110,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Ospedale Cisanello","Pisa",{"type":99,"coordinates":125},[126,127],10.4036,43.70853,{"lat":127,"lon":126},[130],{"name":131,"role":85,"phone":132,"phoneExt":56,"email":133},"Dr.Marco De Carlo","+39 050 971 9530","urp@ao-pisa.toscana.it",{"facility":135,"status":94,"city":136,"state":56,"zip":56,"country":109,"countryCode":110,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Azienda Ospedaliera Regionale -S.Carlo","Potenza",{"type":99,"coordinates":138},[139,140],15.80794,40.64175,{"lat":140,"lon":139},[143],{"name":144,"role":85,"phone":145,"phoneExt":56,"email":146},"Eugenio Stabile","+39 81 746 2228\u002F53","eugeniostabile@gmail.com",{"facility":148,"status":94,"city":149,"state":56,"zip":56,"country":150,"countryCode":151,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Hospital de Santa Cruz","Carnaxide","Portugal","PT",{"type":99,"coordinates":153},[154,155],-9.24671,38.72706,{"lat":155,"lon":154},[158],{"name":159,"role":85,"phone":160,"phoneExt":56,"email":161},"Rui Teles","+351 21 043 1000","rcteles@outlook.com",{"facility":163,"status":94,"city":164,"state":56,"zip":56,"country":165,"countryCode":166,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Hospital Universitario de a Coruna","A Coruña","Spain","ES",{"type":99,"coordinates":168},[169,170],-8.396,43.37135,{"lat":170,"lon":169},[173],{"name":174,"role":85,"phone":175,"phoneExt":56,"email":176},"Dr Pablo Pinon","+34 981 17 80 00","info@jjphospitalaria.com",{"facility":178,"status":94,"city":179,"state":56,"zip":56,"country":165,"countryCode":166,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Hospital Clínico San Carlos","Madrid",{"type":99,"coordinates":181},[182,183],-3.70256,40.4165,{"lat":183,"lon":182},[186],{"name":187,"role":85,"phone":188,"phoneExt":56,"email":189},"Dr.Luis Nombel","91 330 30 00","gerent.hcsc@salud.madrid.org",{"facility":191,"status":94,"city":192,"state":56,"zip":56,"country":165,"countryCode":166,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"Hospital clinico Universitario de Valladolid","Valladolid",{"type":99,"coordinates":194},[195,196],-4.72353,41.65541,{"lat":196,"lon":195},[199],{"name":200,"role":85,"phone":201,"phoneExt":56,"email":202},"Dr. Filippo Pensotti","+34 983 42 00 00","ceim.asva@saludcastillayleon.esjalvarezgo",{"facility":204,"status":94,"city":205,"state":56,"zip":56,"country":206,"countryCode":207,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Luzerner Kantonsspital | Herzzentrum","Lucerne","Switzerland","CH",{"type":99,"coordinates":209},[210,211],8.30635,47.05048,{"lat":211,"lon":210},[214],{"name":215,"role":85,"phone":216,"phoneExt":56,"email":217},"Dr.Stefan Toggweiler","0412051111","ifo@luks.ch",{"type":219,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100557249","vitaflow-liberty-europe-100557249",false,"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)","ALL","18 Years",{"count":230,"type":231},222,"ESTIMATED","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.",[235],"Aortic Valve Stenosis",[237],"Transcatheter aortic valve replacement","2026-09-28",{"date":240,"type":241},"2026-10-01","ACTUAL",{"date":243,"type":241},"2025-05-06",{"date":245,"type":231},"2033-06",{"name":5,"class":6},9]