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New heart device for babies: safer alternative to surgery?

NCT ID NCT05264753

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 255 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Full Analysis Set (safety): All patients intended to be treated with PDA Full Analysis Set (efficacy): All patients with implanted PDA

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * A subject of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Including subjects more than 3 kg. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) defects. * Male or female subjects. * Subjects or their parents/guardians understanding the nature of the study and providing their informed consent to participation. * Subjects willing and able to attend the follow-up visits and procedures foreseen by study CIP. Exclusion Criteria: Contraindications as laid down in the IFU: * Silent ductus or serious pulmonary hypertension: * Pulmonary Vascular Resistance (PVR) \> 8 Wood Units * Presence of a known coagulation disorder * Thrombus at the position allocated for the implantation * A vein thrombosis in the blood vessels chosen for the introducing system * An active infection (active endocarditis or other infections causing bacteremia) or history of endocarditis within 3 months from the procedure. * Nitinol intolerance (nickel or titanium) * Contrast medium intolerance * Subjects who have a vascular system (which is used to access the defect) that is too small to admit the required sheath

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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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