[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464565":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":126,"collaborators":10,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":130,"sex":136,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":142,"studyType":143,"phases":10,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":112,"whyStopped":10,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Occlutech International AB","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"muscular ventricular septal defects",null,"patients with muscular ventricular septal defects",[13],"Device: Occlutech muscular ventricular septal defect (mVSD) Occluder",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"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).",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Ahmed Della","CONTACT","+49 151 14139961","ahmed.dellaa@occlutech.com",[27,47,72,92,110],{"facility":28,"status":29,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Children's Health Ireland","NOT_YET_RECRUITING","Dublin","N512","Ireland","IE",{"type":35,"coordinates":36},"Point",[37,38],-6.24889,53.33306,{"lat":38,"lon":37},[41,45],{"name":42,"role":23,"phone":43,"phoneExt":10,"email":44},"Damien Kenny, MD","00353 85 757 85 56","damien_kenny@icloud.com",{"name":46,"role":23,"phone":10,"phoneExt":10,"email":10},"Claire Josephine Karungi Betz, SC",{"facility":48,"status":29,"city":49,"state":50,"zip":51,"country":52,"countryCode":10,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"İzmir Şehir Hastanesi","Izmir","Bayraklı","35540","Turkey (Türkiye)",{"type":35,"coordinates":54},[55,56],27.13838,38.41273,{"lat":56,"lon":55},[59,63,67,69],{"name":60,"role":23,"phone":61,"phoneExt":10,"email":62},"Nazmi Narin, MD","+90 533 770 64 94","nazmi.narin@gmail.com",{"name":64,"role":23,"phone":65,"phoneExt":10,"email":66},"Kumru Bademci, SC","+90 539 895 96 25","kumru.bademci@medex-smo.com",{"name":60,"role":68,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":70,"role":71,"phone":10,"phoneExt":10,"email":10},"Kaan Yıldız, Assoc. Prof. Dr., MD","SUB_INVESTIGATOR",{"facility":73,"status":29,"city":74,"state":75,"zip":76,"country":52,"countryCode":10,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Eskişehir Osmangazi Üniversite Hastanesi","Eskişehir","Odunpazarı","26040",{"type":35,"coordinates":78},[79,80],30.52056,39.77667,{"lat":80,"lon":79},[83,87,91],{"name":84,"role":23,"phone":85,"phoneExt":10,"email":86},"Birsen Uçar, MD","+90 506 397 85 85","drbucar@yahoo.com",{"name":88,"role":23,"phone":89,"phoneExt":10,"email":90},"Çiçek Kır, SC","+90 531 6974619","cicek.kir@medex-smo.com",{"name":84,"role":68,"phone":10,"phoneExt":10,"email":10},{"facility":93,"status":29,"city":94,"state":95,"zip":10,"country":52,"countryCode":10,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Dicle Üniversitesi Tıp Fakültesi Hastanesi","Diyarbakır","Sur",{"type":35,"coordinates":97},[98,99],40.21721,37.91363,{"lat":99,"lon":98},[102,106],{"name":103,"role":23,"phone":104,"phoneExt":10,"email":105},"Alper Akın, MD","+90 542 256 06 01","alperakin1@hotmail.com",{"name":107,"role":23,"phone":108,"phoneExt":10,"email":109},"Merve Demirtaş, SC","+90 549 6101287","merve.demirtas@medex-smo.com",{"facility":111,"status":112,"city":113,"state":114,"zip":115,"country":52,"countryCode":10,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Gaziantep Unıversıty Hospital","RECRUITING","Gaziantep","Şehitkamil","27310",{"type":35,"coordinates":117},[118,119],37.3825,37.05944,{"lat":119,"lon":118},[122],{"name":123,"role":23,"phone":124,"phoneExt":10,"email":125},"Osman Başpınar, MD","+90 532 345 54 77","osmanbaspinar@hotmail.com",{"type":127,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100464565","follow-up-study-to-monitor-the-efficacy-and-safety-of-the-occlutech-mvsd-cases-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":140,"type":141},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.",[146],"Muscular Ventricular Septal Defect",[148,149,150,151,152,153,154,155,156,157,158,159,160],"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":163,"type":164},"2026-02-02","ACTUAL",{"date":166,"type":164},"2022-03-03",{"date":168,"type":141},"2029-10-01",{"name":5,"class":6},5]