[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464565":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":20,"studyPopulation":21,"armGroups":22,"interventions":28,"overallOfficials":16,"centralContacts":34,"locations":40,"responsibleParty":140,"collaborators":16,"id":142,"slug":16,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":143,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":155,"studyType":156,"phases":16,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":126,"whyStopped":16,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"Occlutech International AB","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"The primary safety endpoint","The primary safety endpoint is defined as the incidence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, ischemic stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explanation, new onset of severe tricuspid regurgitation (TR), new the onset of severe aortic regurgitation (AR), severe right-left ventricular outflow obstruction (RVOTO-LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open heart surgery up to 1 year after the mVSD closure procedure.","1 year",{"measure":14,"description":15,"timeFrame":12},"The primary efficacy endpoint","The primary efficacy endpoints will include data obtained 1 year after the mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as the reduction in muscular ventricular septal shunt to trivial or no shunt at all, as assessed by echocardiography pre- vs post-implantation).",null,{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":18,"timePerspective":19,"maskingInfo":16},"CASE_ONLY","PROSPECTIVE","This is a multicenter, prospective, and retrospective, international, post-market clinical follow-up Study to monitor the efficacy and safety of the Occlutech mVSD in patients with muscular ventricular septal defects.\n\nSafety and efficacy of implanted devices are assessed by echocardiography, vital signs, laboratory tests, and ECGs on Day 1 (within 48 hours post-procedure), follow-up 1 (between Day 30 and Day 60), follow-up 2 at 6 months (from Day 61 until 6 months), follow-up 3 at 1 year (from 6 months until 1 year), and follow-up 4 at 3 years (from 1 year until 3 years).\n\n* Patients will be screened to determine eligibility for the registry based on inclusion\u002Fexclusion criteria, through their medical history, demographics, vital signs, clinical laboratory tests, performance of a 12 lead electrocardiogram (ECG) and echocardiography data.\n* Participants are treated according to the instructions-for-use (IFU) of the device and according to clinical routine.\n* Procedures are performed at sites having appropriate laboratory support and adequately trained imaging personnel. The procedure is performed by physicians with experience in a wide range of interventional cardiology and structural heart disease, including transcatheter patent ductus arteriosus, atrial septal defect, and ventricular septal defect (VSD) closures.\n\nRecruitment will be open until 50 Patients have been enrolled. The primary safety endpoint is defined as the incidence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, ischemic stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explanation, new onset of severe tricuspid regurgitation (TR), new the onset of severe aortic regurgitation (AR), severe right-left ventricular outflow obstruction (RVOTO-LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open heart surgery up to 1 year after the mVSD closure procedure.\n\nThe primary efficacy endpoints will include data obtained 1 year after the mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as the reduction in muscular ventricular septal shunt to trivial or no shunt at all, as assessed by echocardiography pre- vs post-implantation).","Male and female patients of any age with a hemodynamically or clinically significant muscular ventricular septal defect (mVSD) who are candidates for non-surgical closure with the Occlutech mVSD Occluder in routine clinical practice (predominantly pediatric patients). Eligibility is confirmed based on protocol-defined inclusion\u002Fexclusion criteria and baseline clinical assessment, including medical history, demographics, vital signs, ECG and echocardiography; laboratory tests may be performed according to local standard of care.",[23],{"label":24,"type":16,"description":25,"interventionNames":26},"muscular ventricular septal defects","patients with muscular ventricular septal defects",[27],"Device: Occlutech muscular ventricular septal defect (mVSD) Occluder",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":16},"DEVICE","Occlutech muscular ventricular septal defect (mVSD) Occluder","Percutaneous, transcatheter (catheter-based) non-surgical closure of a muscular ventricular septal defect (mVSD) using the Occlutech mVSD Occluder. The device is a self-expandable nitinol wire-mesh occluder with two retention discs connected by a flexible waist and incorporates polyester\u002FPET patches to support defect occlusion and tissue ingrowth. Implantation is performed by experienced operators in a specialized cath lab according to the IFU and local routine; device sizing\u002Fselection is guided by imaging (e.g., transthoracic echocardiography, angiography, fluoroscopy). The system is deployed using compatible Occlutech delivery accessories (e.g., Occlutech Pistol Pusher and Occlutech Delivery Set \\[ODS v1 or ODS III\\], as applicable).",[24],[35],{"name":36,"role":37,"phone":38,"phoneExt":16,"email":39},"Ahmed Della","CONTACT","+49 151 14139961","ahmed.dellaa@occlutech.com",[41,61,86,106,124],{"facility":42,"status":43,"city":44,"state":16,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Children's Health Ireland","NOT_YET_RECRUITING","Dublin","N512","Ireland","IE",{"type":49,"coordinates":50},"Point",[51,52],-6.24889,53.33306,{"lat":52,"lon":51},[55,59],{"name":56,"role":37,"phone":57,"phoneExt":16,"email":58},"Damien Kenny, MD","00353 85 757 85 56","damien_kenny@icloud.com",{"name":60,"role":37,"phone":16,"phoneExt":16,"email":16},"Claire Josephine Karungi Betz, SC",{"facility":62,"status":43,"city":63,"state":64,"zip":65,"country":66,"countryCode":16,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"İzmir Şehir Hastanesi","Izmir","Bayraklı","35540","Turkey (Türkiye)",{"type":49,"coordinates":68},[69,70],27.13838,38.41273,{"lat":70,"lon":69},[73,77,81,83],{"name":74,"role":37,"phone":75,"phoneExt":16,"email":76},"Nazmi Narin, MD","+90 533 770 64 94","nazmi.narin@gmail.com",{"name":78,"role":37,"phone":79,"phoneExt":16,"email":80},"Kumru Bademci, SC","+90 539 895 96 25","kumru.bademci@medex-smo.com",{"name":74,"role":82,"phone":16,"phoneExt":16,"email":16},"PRINCIPAL_INVESTIGATOR",{"name":84,"role":85,"phone":16,"phoneExt":16,"email":16},"Kaan Yıldız, Assoc. Prof. Dr., MD","SUB_INVESTIGATOR",{"facility":87,"status":43,"city":88,"state":89,"zip":90,"country":66,"countryCode":16,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Eskişehir Osmangazi Üniversite Hastanesi","Eskişehir","Odunpazarı","26040",{"type":49,"coordinates":92},[93,94],30.52056,39.77667,{"lat":94,"lon":93},[97,101,105],{"name":98,"role":37,"phone":99,"phoneExt":16,"email":100},"Birsen Uçar, MD","+90 506 397 85 85","drbucar@yahoo.com",{"name":102,"role":37,"phone":103,"phoneExt":16,"email":104},"Çiçek Kır, SC","+90 531 6974619","cicek.kir@medex-smo.com",{"name":98,"role":82,"phone":16,"phoneExt":16,"email":16},{"facility":107,"status":43,"city":108,"state":109,"zip":16,"country":66,"countryCode":16,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Dicle Üniversitesi Tıp Fakültesi Hastanesi","Diyarbakır","Sur",{"type":49,"coordinates":111},[112,113],40.21721,37.91363,{"lat":113,"lon":112},[116,120],{"name":117,"role":37,"phone":118,"phoneExt":16,"email":119},"Alper Akın, MD","+90 542 256 06 01","alperakin1@hotmail.com",{"name":121,"role":37,"phone":122,"phoneExt":16,"email":123},"Merve Demirtaş, SC","+90 549 6101287","merve.demirtas@medex-smo.com",{"facility":125,"status":126,"city":127,"state":128,"zip":129,"country":66,"countryCode":16,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Gaziantep Unıversıty Hospital","RECRUITING","Gaziantep","Şehitkamil","27310",{"type":49,"coordinates":131},[132,133],37.3825,37.05944,{"lat":133,"lon":132},[136],{"name":137,"role":37,"phone":138,"phoneExt":16,"email":139},"Osman Başpınar, MD","+90 532 345 54 77","osmanbaspinar@hotmail.com",{"type":141,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100464565",false,"NCT05329350","Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases","A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Muscular Ventricular Septal Defect (mVSD) Occluder in Patients With Muscular Ventricular Septal Defects","mVSD Registry","Inclusion Criteria\n\n* A participant will be eligible for study participation if he\u002Fshe meets the indication and area of application as laid down in the IFU. The Occlutech mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.\n* Any age\n* Male or female.\n* Patients understand the nature of the study and provide their informed consent to participation.\n* Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.\n\nContraindication\n\n* Hemodynamically relevant VSD shunt\n* Congestive heart insufficiency\n* Recurrent respiratory infections\n* Failure to thrive.\n* Significant left ventricle (LV) enlargement\n* Significant left atrium (LA) enlargement\n* Other clinical indication\n\nExclusion Criteria\n\nThe device is contraindicated for participants known to have any of the following:\n\n⦁Active bacterial infections\n\n* Active infection at the time of implantation\n* Allergy to antiplatelet or anticoagulant therapy\n* Allergy to nickel and\u002For titanium and\u002For nickel\u002Ftitanium-based materials\n* Any type of serious infection 1 month before the procedure\n* The aortic rim of less than 2 mm\n* Demonstrated intracardiac thrombi on echocardiography\n* Malignancy where life expectancy is less than 3 years\n* mVSD diameter \\> 20 mm\n* Perimembranous VSD\n\nPost-MI VSD\n\n* Recent myocardial infarction or a surgical bypass operation in the last 30 days\n* Sepsis (local or generalized)\n* Septal thickness \\> 7 mm in the area of the Occluder placement","ALL","3 Months","80 Years",{"count":153,"type":154},50,"ESTIMATED","3 Years","OBSERVATIONAL","The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.\n\nThe objectives of the study are:\n\n* To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.\n* To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.",[159],"Muscular Ventricular Septal Defect",[161,162,163,164,165,166,167,168,169,170,171,172,173],"mVSD Occluder","mVSD","Occlutech","Occlutech mVSD Occluder","Muscular ventricular septal defect closure","Transcatheter closure","Percutaneous occlusion","Periventricular closure","Post-market clinical follow-up","PMCF","Congenital heart defect","Structural heart disease intervention","Echocardiography follow-up","2026-01-29",{"date":176,"type":177},"2026-02-02","ACTUAL",{"date":179,"type":177},"2022-03-03",{"date":181,"type":154},"2029-10-01",{"name":5,"class":6},5]