[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596063":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":69,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":79,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"First Affiliated Hospital of Guangxi Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BioOccl-VSD",null,"Patients with outlet ventricular septal defects undergoing transcatheter closure with bioabsorbable occluders.",[13],"Device: transcatheter closure of outlet VSDs with bioabsorbable occluders",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","transcatheter closure of outlet VSDs with bioabsorbable occluders","Transcatheter closure of outlet ventricular septal defects using a bioabsorbable occluder (Shape Memory Alloy Ltd, Shanghai, China). Implantation is performed via femoral\u002Ftransthoracic approach under echocardiographic guidance following standard interventional protocols.",[9],[21],{"name":22,"affiliation":5,"role":23},"Liuliu Huang, MD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+8618577780131","dochuangllgxnn@gmail.com",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Ji Wu, MD","+8613978862109","gxnnwuji@163.com",[34],{"facility":35,"status":10,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi","530021","China","CN",{"type":42,"coordinates":43},"Point",[44,45],108.31667,22.81667,{"lat":45,"lon":44},[48,49,53],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},{"name":50,"role":26,"phone":51,"phoneExt":10,"email":52},"Baoshi Zheng, MD","+8613977189015","Zhengbs25@vip.sina.com",{"name":22,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100596063","bioabsorbable-occluder-for-outlet-vsd-safety-and-aortic-valve-effects-100596063",false,"NCT07040579","Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects","Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function","ABSORB-VSD","Inclusion Criteria:\n\n* Age ≥1 year and weight ≥10 kg\n* Outlet VSD without ventricular malalignment\n* Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography\n* Written informed consent\n\nExclusion Criteria:\n\n* Outlet VSD with a fibrous postero-inferior rim\n* Concurrent cardiac conditions requiring surgical correction\n* Severe pulmonary hypertension (PVR \\> 5 WU, assessed by right heart catheterization )\n* Intracardiac thrombus\n* Pregnancy\n* Active systemic infection within 1 month","ALL","1 Year",{"count":67,"type":68},50,"ESTIMATED","5 Years","OBSERVATIONAL","This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function.",[73,74],"Congenital Heart Defects","VSD",[76,77,78],"transcatheter","bioabsorbable occluder","outlet VSD","NOT_YET_RECRUITING","2025-06-18",{"date":82,"type":83},"2025-06-27","ACTUAL",{"date":85,"type":68},"2025-06-30",{"date":87,"type":68},"2032-12-31",{"name":5,"class":6},1]