[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641895":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":13,"responsibleParty":36,"collaborators":7,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":7,"eligibilityCriteria":43,"healthyVolunteers":40,"sex":44,"minAge":45,"maxAge":7,"enrollmentInfo":46,"targetDuration":7,"studyType":49,"phases":7,"briefSummary":50,"conditions":51,"keywords":7,"overallStatus":16,"whyStopped":7,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},{"fullName":5,"class":6},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","HeartR™ PDA Occluder","Lifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA).",[14],{"facility":15,"status":16,"city":17,"state":18,"zip":19,"country":20,"countryCode":21,"cosmosGeoPoint":22,"geoPoint":27,"contacts":28},"RS Awal Bros","RECRUITING","Pekanbaru","Riau","28156","Indonesia","ID",{"type":23,"coordinates":24},"Point",[25,26],101.44167,0.51667,{"lat":26,"lon":25},[29,34],{"name":30,"role":31,"phone":32,"phoneExt":7,"email":33},"Shirley Leonita Anggriawan, Dr. Sp.A (K)","CONTACT","0761-47333","mkt.pku@awalbros.com",{"name":30,"role":35,"phone":7,"phoneExt":7,"email":7},"PRINCIPAL_INVESTIGATOR",{"type":37,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100641895","heartr-pda-occluder-post-market-follow-up-study-100641895",false,"NCT07646704","HeartR™ PDA Occluder Post-Market Follow-Up Study","Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) and were implanted with the HeartR™ PDA Occluder as per IFU instructions\n2. Age ≥ 6 months at the time of implantation.\n3. Weighing ≥ 6 kg at the time of implantation.\n4. Narrowest portion of the PDA ≥ 2mm at the time of implantation.\n\nExclusion Criteria:\n\nPatients did not conduct any follow up visit after hospital discharge.","ALL","6 Months",{"count":47,"type":48},140,"ESTIMATED","OBSERVATIONAL","The HeartR™ PDA Occluder Post-Market Clinical Follow-up (PMCF) Study is a multi-center, retrospective, single-arm study sponsored by Lifetech Scientific (Shenzhen) Co., Ltd., aiming to evaluate the long-term safety and performance of the Lifetech HeartR™ PDA Occluder in real-world clinical practice in Indonesia. A total of 140 subjects diagnosed with Patent Ductus Arteriosus (PDA) and treated with the HeartR™ PDA Occluder according to the Instructions for Use (IFU) will be enrolled.\n\nEligible subjects include patients aged ≥6 months, weighing ≥6 kg, with a PDA narrowest diameter ≥2 mm at the time of implantation. Patients without any follow-up visit after hospital discharge will be excluded from the study.\n\nThe primary endpoint is procedural success at 12 months post-implantation, defined as the absence of major adverse events including stroke\u002FTIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention, and procedure\u002Fdevice-related death, together with complete defect closure confirmed by Doppler echocardiography without residual shunt.\n\nSecondary endpoints include complete closure rates before discharge and at 6 months post-implantation, incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention, incidence of device- or procedure-related adverse events (AEs) and serious adverse events (SAEs), as well as all-cause mortality through 24 months post-implantation.",[52],"Patent Ductus Arteriosus","2026-06-09",{"date":55,"type":56},"2026-06-15","ACTUAL",{"date":58,"type":56},"2025-04-30",{"date":60,"type":48},"2026-12-31",{"name":5,"class":6},1]