Heart hole closer device put to the test in Real-World study
NCT ID NCT07646704
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.
Disclaimer
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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RS Awal Bros
RECRUITINGPekanbaru, Riau, 28156, Indonesia
Contact Phone: •••-•••-•••• Email: •••••@•••••
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