Heart device for preemies under scrutiny in new safety study

NCT ID NCT04371081

Ongoing Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

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.

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

Showa University Hospital

Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.