New heart device for babies: safer alternative to surgery?
NCT ID NCT05264753
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
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.
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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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Aydın Adnan Menderes University Hospital
RECRUITINGAydin, Efeler, Turkey (Türkiye)
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
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CHU Sainte-Justine
NOT_YET_RECRUITINGMontreal, Canada
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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CHU de Lille - Institut Cœur-Poumon
NOT_YET_RECRUITINGLille, France
Contact Phone: •••-•••-••••
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Children's Hospital Ireland at Crumlin
NOT_YET_RECRUITINGDublin, Ireland
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Children´s Hospital, Karolinska University
NOT_YET_RECRUITINGStockholm, Sweden
Contact
Contact Email: •••••@•••••
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Dicle University Hospital
RECRUITINGDiyarbakır, SUR, Turkey (Türkiye)
Contact Email: •••••@•••••
Contact
Contact
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Eskişehir Osmangazi University Hospital
RECRUITINGEskişehir, Eskişehir, 26040, Turkey (Türkiye)
Contact
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hospital La Rabta
RECRUITINGTunis, Tunisia
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Hôpital Mère Enfant, CHU de Nantes
RECRUITINGNantes, France
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Insel Gruppe
NOT_YET_RECRUITINGBern, Switzerland
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Military Hospital
RECRUITINGTunis, Tunisia
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Contact Email: •••••@•••••
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Contact
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Ospedale Pediatrico Bambino Gesù
RECRUITINGRoma, Roma, 00146, Italy
Contact Phone: •••-•••-•••• Email: •••••@•••••
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Rawalpindi Institute of Cardiology
RECRUITINGRawalpindi, Rawalpindi, Pakistan
Contact
Contact Email: •••••@•••••
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Royal Brompton & Harefield Hospitals
RECRUITINGLondon, London, SW3 6NP, United Kingdom
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
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Çukurova University Hospital
RECRUITINGAdana, Sarıçam, Turkey (Türkiye)
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
Contact