[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641895":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":31,"armGroups":27,"interventions":32,"overallOfficials":27,"centralContacts":27,"locations":37,"responsibleParty":60,"collaborators":27,"id":62,"slug":27,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":27,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":27,"enrollmentInfo":69,"targetDuration":27,"studyType":72,"phases":27,"briefSummary":73,"conditions":74,"keywords":27,"overallStatus":40,"whyStopped":27,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Procedural success","1. Absence of stroke\u002FTIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention and procedure\u002Fdevice related death at 12 months post-implantation.\n2. Complete closure of the defects, with no residual shunt confirmed by Doppler echocardiography at 12 months post-implantation.","12 months post-implantation",[14,17,20,23,25],{"measure":15,"description":15,"timeFrame":16},"Complete closure of the defects with no residual shunt","before discharge and at 6 months post-implantation",{"measure":18,"description":18,"timeFrame":19},"Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention","before discharge and at 6 months, 12 months post-implantation",{"measure":21,"description":21,"timeFrame":22},"Incidence of device or procedure related Adverse Events (AEs)","from attempted procedure to 24 months post-implantation",{"measure":24,"description":24,"timeFrame":22},"Incidence of device or procedure related Serious Adverse Events (SAEs)",{"measure":26,"description":26,"timeFrame":22},"Incidence of death",null,{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":29,"timePerspective":30,"maskingInfo":27},"CASE_ONLY","RETROSPECTIVE","The study population consists of patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) who underwent transcatheter closure using the Lifetech HeartR™ PDA Occluder in accordance with the Instructions for Use (IFU) in routine clinical practice in Indonesia. Eligible subjects were aged 6 months or older, weighed at least 6 kg, and had a PDA with a narrowest diameter of at least 2 mm at the time of implantation. Only patients with available post-discharge follow-up data will be included in the study.",[33],{"type":34,"name":35,"description":36,"armGroupLabels":27,"otherNames":27},"DEVICE","HeartR™ PDA Occluder","Lifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA).",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RS Awal Bros","RECRUITING","Pekanbaru","Riau","28156","Indonesia","ID",{"type":47,"coordinates":48},"Point",[49,50],101.44167,0.51667,{"lat":50,"lon":49},[53,58],{"name":54,"role":55,"phone":56,"phoneExt":27,"email":57},"Shirley Leonita Anggriawan, Dr. Sp.A (K)","CONTACT","0761-47333","mkt.pku@awalbros.com",{"name":54,"role":59,"phone":27,"phoneExt":27,"email":27},"PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","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":70,"type":71},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.",[75],"Patent Ductus Arteriosus","2026-06-09",{"date":78,"type":79},"2026-06-15","ACTUAL",{"date":81,"type":79},"2025-04-30",{"date":83,"type":71},"2026-12-31",{"name":5,"class":6},1]