HeartR PDA Occluder: Long-Term Follow-Up in Indonesian Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a retrospective, multi-center, single-arm study conducted in Indonesia to observe the long-term safety and performance of the HeartR PDA Occluder. It includes patients aged 6 months or older, weighing at least 6 kg, with PDA narrowing of 2 mm or more who were treated according to the device’s instructions for use. The primary endpoint is procedural success at 12 months after implantation, focusing on the absence of major adverse events such as stroke, device embolization, vascular or cardiac injury, or the need for re-intervention due to stenosis. Enrollment targets 140 subjects and relies on previously implanted cases with follow-up data. The study is sponsored by Lifetech Scientific and conducted at RS Awal Bros Pekanbaru in Riau, Indonesia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) and were implanted with the HeartR™ PDA Occluder as per IFU instructions
2. Age ≥ 6 months at the time of implantation.
3. Weighing ≥ 6 kg at the time of implantation.
4. Narrowest portion of the PDA ≥ 2mm at the time of implantation.

Exclusion Criteria:

Patients did not conduct any follow up visit after hospital discharge.

Where it's running

• RS Awal Bros
  Pekanbaru, Riau, Indonesia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.