New heart device for babies: safer alternative to surgery?

NCT ID NCT05264753

Recruiting now Disease control Sponsor: Occlutech International AB Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 13, 2026 · Updated 5 times

Summary

This study follows 255 patients of any age (weighing over 3 kg) who receive a device called the Occlutech PDA Occluder to close a common heart defect called patent ductus arteriosus (PDA). The device is inserted through a blood vessel, avoiding open-heart surgery. Researchers will check safety and effectiveness for up to 3 years after the procedure, looking for serious complications and whether the hole stays closed.

What this could mean

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

Active substance: Occlutech PDA Occluder (a device inserted through a blood vessel to close a hole in the heart)
What this could lead to: If successful, this could confirm that the device is a safe, non-surgical option to close a common heart defect in children, reducing the need for open-heart surgery.
What could go wrong: This is an observational follow-up study, not a randomized trial, so results may be less definitive. Risks include serious complications like device movement, infection, or stroke, though these are expected to be rare.

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

Aydın Adnan Menderes University Hospital
RECRUITING

Aydin, Efeler, Turkey (Türkiye)
CHU Sainte-Justine
NOT_YET_RECRUITING

Montreal, Canada
CHU de Lille - Institut Cœur-Poumon
NOT_YET_RECRUITING

Lille, France
Children´s Hospital, Karolinska University
RECRUITING

Stockholm, Sweden
Dicle University Hospital
RECRUITING

Diyarbakır, SUR, Turkey (Türkiye)
Eskişehir Osmangazi University Hospital
RECRUITING

Eskişehir, Eskişehir, 26040, Turkey (Türkiye)
Hospital La Rabta
RECRUITING

Tunis, Tunisia
Hôpital Marie Lannelongue
NOT_YET_RECRUITING

Le Plessis-Robinson, Paris, 92350, France
Hôpital Mère Enfant, CHU de Nantes
RECRUITING

Nantes, France
Insel Gruppe
NOT_YET_RECRUITING

Bern, Switzerland
Military Hospital
RECRUITING

Tunis, Tunisia
Ospedale Pediatrico Bambino Gesù
RECRUITING

Roma, Roma, 00146, Italy
Rawalpindi Institute of Cardiology
RECRUITING

Rawalpindi, Rawalpindi, Pakistan
Royal Brompton & Harefield Hospitals
RECRUITING

London, London, SW3 6NP, United Kingdom
Çukurova University Hospital
RECRUITING

Adana, Sarıçam, Turkey (Türkiye)

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