Heart hole closer device put to the test in Real-World study

NCT ID NCT07646704

Recruiting now Disease control Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 140 patients in Indonesia who received the HeartR PDA Occluder, a device that closes a common heart defect called Patent Ductus Arteriosus (PDA). The goal is to see if the device works well and is safe over 12 to 24 months. Patients must be at least 6 months old and weigh at least 6 kg. The study checks for complications like stroke, device movement, or incomplete closure.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: HeartR™ PDA Occluder (a device to close a hole in the heart)
What this could lead to: If successful, this study confirms the device is safe and effective for closing a common heart defect, helping patients avoid surgery.
What could go wrong: This is a post-market study with no control group, so results may not apply to all patients. Some risks include device movement or blood clots.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

patent ductus arteriosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PATENT DUCTUS ARTERIOSUS

Contacts and locations

Locations

RS Awal Bros
RECRUITING

Pekanbaru, Riau, 28156, Indonesia

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