Heart device for preemies under scrutiny in new safety study
NCT ID NCT04371081
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study monitors 70 infants who receive the Amplatzer Piccolo Occluder to close a hole in the heart called patent ductus arteriosus (PDA). The device is placed through a blood vessel, avoiding open-heart surgery. Researchers track complications and how well the hole closes over 6 months.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Amplatzer Piccolo Occluder (a small device placed in the heart to close a hole)
What this could lead to
If successful, this study confirms that the device is safe and works well for closing a common heart defect in premature and low-weight babies.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove cause and effect. Risks include device-related complications like blood clots or improper closure.
Disclaimer
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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.
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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Showa University Hospital
Tokyo, Japan