Long-Term Safety and Performance of the HeartR PDA Occluder in Indonesian Patients with Patent Ductus Arteriosus

What this Trial Is About

This research aims to assess the long-term safety and performance of the Lifetech HeartR PDA Occluder device in patients diagnosed with Patent Ductus Arteriosus PDA treated in real-world clinical practice settings in Indonesia. The study is retrospective and single-arm, enrolling 140 subjects who have received the HeartR PDA Occluder according to the devices instructions for use. The main goal is to understand how well the device works and its safety over time in everyday medical use. The study involves patients who were implanted with the HeartR PDA Occluder device via a transcatheter procedure for PDA closure. Eligible patients are those aged 6 months or older, weighing at least 6 kg, and having a PDA narrowest diameter of 2 mm or more at implantation. The study collects data retrospectively from patients who had follow-up visits after hospital discharge, focusing on device performance and safety outcomes over months to years after implantation. Participants records are reviewed for procedural success at 12 months post-implantation, which includes no major complications and complete defect closure verified by Doppler echocardiography. Secondary outcomes such as closure rates before discharge and at 6 months, incidence of artery stenosis requiring re-intervention, device or procedure-related adverse events, serious adverse events, and overall mortality up to 24 months post-implantation are also evaluated. The study spans data collection until the end of 2026, providing long-term monitoring of outcomes in this patient group.

HeartR™ PDA Occluder Post-Market Follow-Up Study