HeartR™ PDA Occluder Post-Market Follow-Up Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HeartR™ PDA Occluder.
- Who it may be relevant to
- Registry conditions: Patent Ductus Arteriosus. Basic parameters: from 6 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device HeartR™ PDA Occluder
Lifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA).
Primary outcome measures
- Procedural success [Time frame: 12 months post-implantation]
Secondary outcome measures (5)
- 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 [Time frame: before discharge and at 6 months, 12 months post-implantation]
- 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) [Time frame: from attempted procedure to 24 months post-implantation]
- Incidence of death [Time frame: from attempted procedure to 24 months post-implantation]
Eligibility criteria
Inclusion criteria
- Patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) and were implanted with the HeartR™ PDA Occluder as per IFU instructions
- Age ≥ 6 months at the time of implantation.
- Weighing ≥ 6 kg at the time of implantation.
- Narrowest portion of the PDA ≥ 2mm at the time of implantation.
Exclusion criteria
Patients did not conduct any follow up visit after hospital discharge.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Indonesia · 1 center
- RS Awal Bros — Pekanbaru
Identifiers
NCT: NCT07646704 · LT-TS-2-2025-01