[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579387":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":40,"studyPopulation":41,"armGroups":42,"interventions":47,"overallOfficials":56,"centralContacts":61,"locations":66,"responsibleParty":298,"collaborators":36,"id":300,"slug":301,"hasResults":302,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":302,"sex":307,"minAge":308,"maxAge":36,"enrollmentInfo":309,"targetDuration":36,"studyType":312,"phases":36,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":69,"whyStopped":36,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},{"fullName":5,"class":6},"Fondation Hôpital Saint-Joseph","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Twelve-month composite non-hierarchical net clinical success","Defined as simultaneous achievement of technical implantation success at procedure conclusion (device successfully deployed and released in the intended position), closure success (complete occlusion or trivial residual shunt), and absence of major adverse device-related events (MADREs), through 12 months.","From implant attempt to 12 months following index procedure",[14,18,21,24,28,32],{"measure":15,"description":16,"timeFrame":17},"Technical success","Successful device deployment and release into the intented position with stable device position confirmed via post-procedure transthoracic echocardiography (TTE).","From implant attempt to procedure conclusion",{"measure":19,"description":20,"timeFrame":12},"Closure success","Complete shunt occlusion or trivial shunt on post-procedure TTE",{"measure":22,"description":23,"timeFrame":12},"Freedom from major device-related major adverse events","Absence of procedure or device-related major adverse events, including:\n\n* Device erosion\n* Device migration or embolization requiring catheter or surgical intervention.\n* Complete heart block requiring permanent pacemaker implantation, device removal, or other medical treatment.\n* New or worsened aortic regurgitation (of mild grade or greater) requiring device removal, close monitoring, or intervention.\n* New or worsened tricuspid regurgitation (of moderate grade or greater) requiring device removal, close monitoring, or intervention.\n* Life-threatening bleeding or significant vascular injury requiring catheter or surgical intervention.\n* Thromboembolic events requiring device removal, thrombolytic therapy, catheter, or surgical intervention.\n* Severe acute hemolysis, requiring blood transfusion device removal, catheter, or surgical intervention.\n* Device-related left or right ventricular outflow tract obstruction\n* Cardiac tamponade",{"measure":25,"description":26,"timeFrame":27},"Minor complications","Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block).","From implant attempt to 60 months following index procedure",{"measure":29,"description":30,"timeFrame":31},"Late-onset device-related major adverse events (MADREs)","Absence of procedure or device-related major adverse events, including:\n\n* Device erosion\n* Device migration or embolization requiring catheter or surgical intervention.\n* Complete heart block requiring permanent pacemaker implantation, device removal, or other medical treatment.\n* New or worsened aortic regurgitation (of mild grade or greater) requiring device removal, close monitoring, or intervention.\n* New or worsened tricuspid regurgitation (of moderate grade or greater) requiring device removal, close monitoring, or intervention.\n* Life-threatening bleeding or significant vascular injury requiring catheter or surgical intervention.\n* Thromboembolic events requiring device removal, thrombolytic therapy, catheter, or surgical intervention.\n* Severe acute hemolysis, requiring blood transfusion device removal, catheter, or surgical intervention.\n* Device-related left or right ventricular outflow tract obstruction\n* Cardiac tamponade\n* Death","From 12 months to 60 months following index procedure",{"measure":33,"description":34,"timeFrame":35},"Functional and quality-of-life measures","Change in NYHA\u002FROSS functional class, and in pediatric patients, catch-up growth.","From implant attempt to 48-month post-procedure",null,{"allocation":36,"interventionModel":36,"interventionModelDescription":36,"primaryPurpose":36,"observationalModel":38,"timePerspective":39,"maskingInfo":36},"COHORT","RETROSPECTIVE","This is a non-randomized, multicenter, international, non-interventional, observational, retrospective post-marketing clinical follow-up study designed to evaluate the feasibility, safety, and efficacy of transcatheter closure of perimembranous ventricular septal defects (PmVSD) using commercially available device occluders, whether specifically designed for this purpose or used off-label.","Patients, regardless of gender or geographical location, with perimembranous ventricular septal defects (PmVSDs) who provided informed consent and underwent transcatheter closure using commercially available occluder devices, whether specifically designed for this purpose or used off-label, were followed according to local hospital protocols.",[43],{"label":44,"type":36,"description":36,"interventionNames":45},"Patients with PmVSDs who provided informed consent and underwent transcatheter closure",[46],"Device: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DEVICE","Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)","Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.",[44],[54,55],"Percutaneous closure of perimembranous ventricular septal defects","Endovascular closure of perimembranous ventricular septal defects",[57],{"name":58,"affiliation":59,"role":60},"Raymond N. Haddad, MD, MHSc, PhDc","Marie Lannelongue Hospital","PRINCIPAL_INVESTIGATOR",[62],{"name":58,"role":63,"phone":64,"phoneExt":36,"email":65},"CONTACT","+33140942800","raymondhaddad@live.com",[67,79,89,100,107,115,123,133,142,150,160,170,180,190,200,210,220,230,240,250,258,267,275,280,288],{"facility":68,"status":69,"city":70,"state":36,"zip":36,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":36},"Copenhagen University Hospital, Rigshospitalet","RECRUITING","Copenhagen","Denmark","DK",{"type":74,"coordinates":75},"Point",[76,77],12.56553,55.67594,{"lat":77,"lon":76},{"facility":80,"status":69,"city":81,"state":36,"zip":36,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":36},"Magdi Yacoub Heart Foundation","Cairo","Egypt","EG",{"type":74,"coordinates":85},[86,87],31.24967,30.06263,{"lat":87,"lon":86},{"facility":90,"status":91,"city":92,"state":36,"zip":36,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":36},"University Hospital of Bordeaux","ENROLLING_BY_INVITATION","Bordeaux","France","FR",{"type":74,"coordinates":96},[97,98],-0.58046,44.84124,{"lat":98,"lon":97},{"facility":59,"status":69,"city":101,"state":36,"zip":36,"country":93,"countryCode":94,"cosmosGeoPoint":102,"geoPoint":106,"contacts":36},"Le Plessis-Robinson",{"type":74,"coordinates":103},[104,105],2.27078,48.78889,{"lat":105,"lon":104},{"facility":108,"status":69,"city":109,"state":36,"zip":36,"country":93,"countryCode":94,"cosmosGeoPoint":110,"geoPoint":114,"contacts":36},"Lille University Hospital","Lille",{"type":74,"coordinates":111},[112,113],3.05512,50.63391,{"lat":113,"lon":112},{"facility":116,"status":69,"city":117,"state":36,"zip":36,"country":93,"countryCode":94,"cosmosGeoPoint":118,"geoPoint":122,"contacts":36},"Toulouse University Hospital","Toulouse",{"type":74,"coordinates":119},[120,121],1.44367,43.60426,{"lat":121,"lon":120},{"facility":124,"status":69,"city":125,"state":36,"zip":36,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":132,"contacts":36},"University Children's Hospital","Tübingen","Germany","DE",{"type":74,"coordinates":129},[130,131],9.05222,48.52266,{"lat":131,"lon":130},{"facility":134,"status":69,"city":135,"state":36,"zip":36,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":36},"Queen Mary Hospital","Hong Kong","HK",{"type":74,"coordinates":138},[139,140],114.17469,22.27832,{"lat":140,"lon":139},{"facility":143,"status":69,"city":144,"state":36,"zip":36,"country":135,"countryCode":136,"cosmosGeoPoint":145,"geoPoint":149,"contacts":36},"Hong Kong Children's Hospital","Kowloon Bay",{"type":74,"coordinates":146},[147,148],114.20777,22.32662,{"lat":148,"lon":147},{"facility":151,"status":69,"city":152,"state":36,"zip":36,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":159,"contacts":36},"National Cardiovascular Center of Harapan Kita","Jakarta","Indonesia","ID",{"type":74,"coordinates":156},[157,158],106.84513,-6.21462,{"lat":158,"lon":157},{"facility":161,"status":69,"city":162,"state":36,"zip":36,"country":163,"countryCode":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":36},"Rajaie Cardiovascular, Medical and Research Center","Tehran","Iran","IR",{"type":74,"coordinates":166},[167,168],51.42151,35.69439,{"lat":168,"lon":167},{"facility":171,"status":69,"city":172,"state":36,"zip":36,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":36},"Hôtel-Dieu de France University Medical Center","Beirut","Lebanon","LB",{"type":74,"coordinates":176},[177,178],35.50157,33.89332,{"lat":178,"lon":177},{"facility":181,"status":69,"city":182,"state":36,"zip":36,"country":183,"countryCode":184,"cosmosGeoPoint":185,"geoPoint":189,"contacts":36},"Hospital de Especialidades Pediátricas","Chiapas","Mexico","MX",{"type":74,"coordinates":186},[187,188],-91.75,16.5,{"lat":188,"lon":187},{"facility":191,"status":91,"city":192,"state":36,"zip":36,"country":193,"countryCode":194,"cosmosGeoPoint":195,"geoPoint":199,"contacts":36},"The Children's Hospital","Lahore","Pakistan","PK",{"type":74,"coordinates":196},[197,198],74.35071,31.558,{"lat":198,"lon":197},{"facility":201,"status":69,"city":202,"state":36,"zip":36,"country":203,"countryCode":204,"cosmosGeoPoint":205,"geoPoint":209,"contacts":36},"Silesian Center for Heart Diseases","Zabrze","Poland","PL",{"type":74,"coordinates":206},[207,208],18.78576,50.32492,{"lat":208,"lon":207},{"facility":211,"status":69,"city":212,"state":36,"zip":36,"country":213,"countryCode":214,"cosmosGeoPoint":215,"geoPoint":219,"contacts":36},"Madinah Cardiac Center MC","Madinah","Saudi Arabia","SA",{"type":74,"coordinates":216},[217,218],39.61417,24.46861,{"lat":218,"lon":217},{"facility":221,"status":69,"city":222,"state":36,"zip":36,"country":223,"countryCode":224,"cosmosGeoPoint":225,"geoPoint":229,"contacts":36},"Skane University Hospital","Skåne","Sweden","SE",{"type":74,"coordinates":226},[227,228],13.33333,59.48333,{"lat":228,"lon":227},{"facility":231,"status":69,"city":232,"state":36,"zip":36,"country":233,"countryCode":234,"cosmosGeoPoint":235,"geoPoint":239,"contacts":36},"University Children's Hospital of Zurich","Zurich","Switzerland","CH",{"type":74,"coordinates":236},[237,238],8.55,47.36667,{"lat":238,"lon":237},{"facility":241,"status":69,"city":242,"state":36,"zip":36,"country":243,"countryCode":244,"cosmosGeoPoint":245,"geoPoint":249,"contacts":36},"Queen Sirikit National Institute of Child Health","Nonthaburi","Thailand","TH",{"type":74,"coordinates":246},[247,248],100.51477,13.86075,{"lat":248,"lon":247},{"facility":251,"status":69,"city":252,"state":36,"zip":36,"country":243,"countryCode":244,"cosmosGeoPoint":253,"geoPoint":257,"contacts":36},"Prince of Songkla University","Songkhla",{"type":74,"coordinates":254},[255,256],100.5951,7.19882,{"lat":256,"lon":255},{"facility":259,"status":69,"city":260,"state":36,"zip":36,"country":261,"countryCode":36,"cosmosGeoPoint":262,"geoPoint":266,"contacts":36},"Ankara City Hospital","Ankara","Turkey (Türkiye)",{"type":74,"coordinates":263},[264,265],32.85427,39.91987,{"lat":265,"lon":264},{"facility":268,"status":69,"city":269,"state":36,"zip":36,"country":261,"countryCode":36,"cosmosGeoPoint":270,"geoPoint":274,"contacts":36},"Koç University","Istanbul",{"type":74,"coordinates":271},[272,273],28.94966,41.01384,{"lat":273,"lon":272},{"facility":276,"status":69,"city":269,"state":36,"zip":36,"country":261,"countryCode":36,"cosmosGeoPoint":277,"geoPoint":279,"contacts":36},"Umraniye Training and Education Hospital",{"type":74,"coordinates":278},[272,273],{"lat":273,"lon":272},{"facility":281,"status":69,"city":282,"state":36,"zip":36,"country":261,"countryCode":36,"cosmosGeoPoint":283,"geoPoint":287,"contacts":36},"SBU Tepecik Training and Research Hospital","Izmir",{"type":74,"coordinates":284},[285,286],27.13838,38.41273,{"lat":286,"lon":285},{"facility":289,"status":69,"city":290,"state":36,"zip":36,"country":291,"countryCode":292,"cosmosGeoPoint":293,"geoPoint":297,"contacts":36},"Al Jalila Children's Speciality Hospital","Dubai","United Arab Emirates","AE",{"type":74,"coordinates":294},[295,296],55.30927,25.07725,{"lat":296,"lon":295},{"type":299,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR","100579387","an-international-multicenter-study-on-transcatheter-device-closure-of-perimembranous-ventricular-septal-defects-100579387",false,"NCT06823635","An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects","PERI-CLOSE","Inclusion Criteria:\n\n1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.\n2. Defect size between 3 mm and \\\u003C20 mm on the left ventricular side, as measured by 2D echocardiography.\n3. Age ≥1 month and body weight ≥5 kg.\n4. Left-to-right ventricular shunt.\n\nExclusion Criteria:\n\n1. Patients or legal guardians refusing the use of personal data for research purposes.\n2. Failure to attend any follow-up visit post-discharge.","ALL","1 Month",{"count":310,"type":311},2000,"ESTIMATED","OBSERVATIONAL","The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).",[315],"Perimembranous Ventricular Septal Defect",[317,318,319,320,321,322,323,324],"Cardiovascular Abnormalities","Congenital Heart Disease","Device Closure","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Ventricular","Transcatheter Interventions","Ventricular Septal Defects","2026-08-24",{"date":327,"type":328},"2026-08-25","ACTUAL",{"date":330,"type":328},"2025-01-01",{"date":332,"type":311},"2027-06-30",{"name":5,"class":6},25]