[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503445":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":32,"studyPopulation":33,"armGroups":28,"interventions":34,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":207,"collaborators":209,"id":216,"slug":28,"hasResults":217,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":217,"sex":223,"minAge":224,"maxAge":225,"enrollmentInfo":226,"targetDuration":229,"studyType":230,"phases":28,"briefSummary":231,"conditions":232,"keywords":28,"overallStatus":76,"whyStopped":28,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"Venus MedTech (HangZhou) Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Non-hierarchical composite endpoint","* Freedom from VenusP-ValveTM (catheter or surgical) reintervention\n* Acceptable hemodynamic function, defined as:\n\n  1. Mild or less regurgitation measured by echocardiography; AND\n  2. Mean RVOT gradient as measured by echocardiography ≤35mmHg.","at six months",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Procedural Success","Procedure success at 30 days, defined as:\n\n* Freedom from procedure\u002Fdevice-related mortality\n* Freedom from Venus P-ValveTM (catheter or surgical) reintervention concerning index procedure or device\n* Acceptable hemodynamic function\n* Original intended valve in situ","at 30 days",{"measure":19,"description":20,"timeFrame":21},"Occurrence of Events","Occurrence of the following events through 5 years of follow-up:\n\n* All-cause mortality and procedure\u002Fdevice-related mortality\n* Venus P-ValveTM (catheter or surgical) reintervention\n* Venus P-ValveTM dysfunction\n* Serious procedure\u002Fdevice-related adverse events","through five years",{"measure":23,"description":24,"timeFrame":21},"Functional status","New York Heart Association (NYHA) classification out to 5 years",{"measure":26,"description":27,"timeFrame":21},"Health-state utility score","Health-state utility score as measured by the EQ-5D at pre-implant, 30 days, 6 months, 1 year and annually thereafter through 5 years.",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":31,"maskingInfo":28},"COHORT","OTHER","All subjects will be followed up through five years for the observed outcome measures, which will be analyzed and reported to regulatory authorities as required.\n\nPost-procedure, a clinical visit will be scheduled at discharge, thirty days, six months, one year, and annually thereafter to five years.","Baseline enrolment criteria\n\n* 12 years old up to 70 years old\n* Weight ≥ 30kg\n* With evidence of moderate or severe (≥3+) pulmonary regurgitation by Transthoracic Echocardiography (TTE)\n* With \\>30% pulmonary regurgitation fraction as defined by cardiac Magnetic Resonance Imaging (MRI)\n* The subject is symptomatic from his\u002Fher pulmonary regurgitation or meets MRI criteria for intervention Right Ventricular Ejection Fraction (RVEF) \\\u003C 45%, Pulmonary Regurgitant Fraction (PRRF) \\>30% and increased Right Ventricular End Diastolic Volume (RVEDV) Index (RVEDVI) \\>150mL\u002Fm²",[35],{"type":36,"name":37,"description":38,"armGroupLabels":28,"otherNames":28},"DEVICE","transcatheter pulmonary valve implantation (TPVI)","A stent-mounted valve is introduced over a guidewire and positioned in the RVOT, followed by balloon inflation to deploy the valve.",[40],{"name":41,"affiliation":42,"role":43},"Shakeel A. Qureshi, MD","Evelina Children's Hospital","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":28,"email":49},"Cong Ma","CONTACT","+86 18817939751","macong@venusmedtech.com",{"name":51,"role":47,"phone":52,"phoneExt":28,"email":53},"Ping Zhang","15802168031","zhangping@venusmedtech.com",[55,74,90,105,119,135,149,165,179,195],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"CHU Bordeaux","NOT_YET_RECRUITING","Pessac","New Aquitaine","33600","France","FR",{"type":64,"coordinates":65},"Point",[66,67],-0.6324,44.80565,{"lat":67,"lon":66},[70],{"name":71,"role":47,"phone":72,"phoneExt":28,"email":73},"Jean-Benoît THAMBO","(+33) 05 57 65 62 59","jean-benoit.thambo@chu-bordeaux.fr",{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":61,"countryCode":62,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Chu Nantes","RECRUITING","Nantes","Pays de la Loire Region","44093",{"type":64,"coordinates":81},[82,83],-1.55336,47.21725,{"lat":83,"lon":82},[86],{"name":87,"role":47,"phone":88,"phoneExt":28,"email":89},"Patrice GUERIN","+33 (0)2 40 16 55 89","patrice.guerin@chu-nantes.fr",{"facility":91,"status":76,"city":92,"state":93,"zip":94,"country":61,"countryCode":62,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Marie Lannelongue","Le Plessis-Robinson","Île-de-France Region","92350",{"type":64,"coordinates":96},[97,98],2.27078,48.78889,{"lat":98,"lon":97},[101],{"name":102,"role":47,"phone":103,"phoneExt":28,"email":104},"Sébastien HASCOËT","+33 6 72 64 10 18","hascoets@gmail.com",{"facility":106,"status":76,"city":107,"state":93,"zip":108,"country":61,"countryCode":62,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Hopital Necker-Enfants malades","Paris","75015",{"type":64,"coordinates":110},[111,112],2.3488,48.85341,{"lat":112,"lon":111},[115],{"name":116,"role":47,"phone":117,"phoneExt":28,"email":118},"MILANI Guiti","0033 1 4494344","guiti.milani@gmail.com",{"facility":120,"status":57,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Heart CenterMunich","Munich","Bavaria","81377","Germany","DE",{"type":64,"coordinates":127},[128,129],11.57549,48.13743,{"lat":129,"lon":128},[132],{"name":133,"role":47,"phone":28,"phoneExt":28,"email":134},"Dr. Stanimir Georgiev","georgiev@dhm.mhn.de",{"facility":136,"status":57,"city":137,"state":138,"zip":139,"country":124,"countryCode":125,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Clinic of Congenital Heart Disease","Berlin","State of Berlin","13353",{"type":64,"coordinates":141},[142,143],13.41053,52.52437,{"lat":143,"lon":142},[146],{"name":147,"role":47,"phone":28,"phoneExt":28,"email":148},"Prof. Felix Berger","mailto:felix.berger@dhzc-charite.de",{"facility":150,"status":57,"city":151,"state":152,"zip":153,"country":154,"countryCode":155,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"OPBG Rome","Rome","Lazio","165","Italy","IT",{"type":64,"coordinates":157},[158,159],12.51133,41.89193,{"lat":159,"lon":158},[162],{"name":163,"role":47,"phone":28,"phoneExt":28,"email":164},"BUTERA GIANFRANCO","gianfrancobutera@libero.it",{"facility":166,"status":57,"city":167,"state":168,"zip":169,"country":154,"countryCode":155,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"S. Donato Milan","Milan","Lombardy","20097",{"type":64,"coordinates":171},[172,173],9.18951,45.46427,{"lat":173,"lon":172},[176],{"name":177,"role":47,"phone":28,"phoneExt":28,"email":178},"Massimo Chessa","massimo.chessa@grupposandonato.it",{"facility":180,"status":57,"city":181,"state":182,"zip":183,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Leeds General Infirmary","Leeds","England","LS1 3EX","United Kingdom","UK",{"type":64,"coordinates":187},[188,189],-1.54785,53.79648,{"lat":189,"lon":188},[192],{"name":193,"role":47,"phone":28,"phoneExt":28,"email":194},"Dr. J. Bentham","Jamie.bentham@nhs.net",{"facility":42,"status":57,"city":196,"state":182,"zip":197,"country":184,"countryCode":185,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"London","SE1 7EH",{"type":64,"coordinates":199},[200,201],-0.12574,51.50853,{"lat":201,"lon":200},[204],{"name":205,"role":47,"phone":28,"phoneExt":28,"email":206},"Prof. Sir S. Qureshi","mailto:Shakeel.Qureshi@gstt.nhs.uk",{"type":208,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR",[210,213],{"name":211,"class":212},"IQVIA MedTech BV of Antwerp, Belgium","UNKNOWN",{"name":214,"class":215},"MDCECRO LLC","NETWORK","100503445",false,"NCT05835349","Observational Study of Venus P-Valve","A Real-World Evidence Observational Study of VenusP-ValveTM System in the Treatment of Patients with Native RVOT Dysfunction","Registry","Inclusion Criteria\n\n1. Patients with native RVOT (including transvalvular patch repair) are present with moderate or greater pulmonary regurgitation with\u002Fwithout stenosis and are clinically indicated for pulmonary valve intervention.\n2. The patient (or the patient's legally authorized representative) is willing to consent to participate in the study and will commit to completing all follow-up requirements.\n\nExclusion Criteria:\n\n1\\. Patients with any condition contraindicated by the IFU or inability to comply with the Venus P-ValveTM System Instructions for Use or the study protocol.","ALL","12 Years","70 Years",{"count":227,"type":228},200,"ESTIMATED","5 Years","OBSERVATIONAL","Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with\u002Fwithout pulmonary stenosis in patients with native right ventricular outflow tract (RVOT).",[233],"Right Ventricular Outflow Tract Dysfunction","2025-01-21",{"date":236,"type":237},"2025-01-24","ACTUAL",{"date":239,"type":237},"2024-08-26",{"date":241,"type":228},"2032-12",{"name":5,"class":6},10]