An observational study in Patent Ductus Arteriosus, sponsored by Lifetech Scientific (Shenzhen) Co., Ltd.. Recruiting at 1 site in Indonesia. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Lifetech Scientific (Shenzhen) Co., Ltd. (part of LifeTech Scientific Corporation) · 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.
Eligible 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.
The primary endpoint is procedural success at 12 months post-implantation, defined as the absence of major adverse events including stroke/TIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention, and procedure/device-related death, together with complete defect closure confirmed by Doppler echocardiography without residual shunt.
Secondary 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.
146 studies on the registry are indexed under Ductus Arteriosus, Patent; 21 are open to participants now.
This study's planned enrollment of 140 is above the median of 81 across 56 observational studies indexed under Ductus Arteriosus, Patent.
Browse Ductus Arteriosus, Patent studies →Lifetech Scientific (Shenzhen) Co., Ltd. is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Patients did not conduct any follow up visit after hospital discharge.
Lifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA).
Procedural success
1. Absence of stroke/TIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention and procedure/device related death at 12 months post-implantation. 2. Complete closure of the defects, with no residual shunt confirmed by Doppler echocardiography at 12 months post-implantation.
Time frame: 12 months post-implantation
Complete closure of the defects with no residual shunt
Complete closure of the defects with no residual shunt
Time frame: before discharge and at 6 months post-implantation
Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
Time frame: before discharge and at 6 months, 12 months post-implantation
Incidence of device or procedure related Adverse Events (AEs)
Incidence of device or procedure related Adverse Events (AEs)
Time frame: from attempted procedure to 24 months post-implantation
Incidence of device or procedure related Serious Adverse Events (SAEs)
Incidence of device or procedure related Serious Adverse Events (SAEs)
Time frame: from attempted procedure to 24 months post-implantation
Incidence of death
Incidence of death
Time frame: from attempted procedure to 24 months post-implantation
Started Apr 2025 (actual). Primary completion is estimated for Dec 2026, 20 months after the start.
How these figures are worked out, and which studies are left out of them.
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