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Can a tiny device fix a hole in the heart without open surgery?

NCT ID NCT06823635

Disease control Sponsor: Fondation Hôpital Saint-Joseph 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Sep 09, 2026 · Updated 5 times

Summary

This international study is evaluating a minimally invasive procedure to close a type of heart defect called a perimembranous ventricular septal defect (PmVSD) — a hole between the heart's lower chambers. The procedure uses a small device inserted through a catheter to plug the hole, avoiding open-heart surgery. The study will include children and adults with this defect and will track how well the device works and whether it leads to complications over a year. The goal is to gather real-world evidence on the safety and effectiveness of this approach across different patients and devices.

What this could mean

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

Active substance
Transcatheter device closure using an occluder device
What this could lead to
If successful, this could establish a safer, less invasive standard for closing perimembranous ventricular septal defects, potentially reducing the need for open-heart surgery.
What could go wrong
The procedure carries risks such as device-related complications or incomplete closure. Outcomes may vary across different devices and patient populations, and long-term benefits are not yet confirmed.

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 2,000 people

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

Started

Jan 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients, regardless of gender or geographical location, with perimembranous ventricular septal defects (PmVSDs) who provided informed consent and underwent transcatheter closure using commercially available occluder devices, whether specifically designed for this purpose or used off-label, were followed according to local hospital protocols.

Ages

1 month and older

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: 1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols. 2. Defect size between 3 mm and \<20 mm on the left ventricular side, as measured by 2D echocardiography. 3. Age ≥1 month and body weight ≥5 kg. 4. Left-to-right ventricular shunt. Exclusion Criteria: 1. Patients or legal guardians refusing the use of personal data for research purposes. 2. Failure to attend any follow-up visit post-discharge.

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Conditions

The condition(s) this trial relates to.

Cardiovascular Abnormalities congenital heart disease heart septal defect ventricular septal defect

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Perimembranous ventricular septal defect

How to take part

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

  1. The places running it

    25 sites in 17 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

  • Al Jalila Children's Speciality Hospital

    RECRUITING

    Dubai, United Arab Emirates

  • Ankara City Hospital

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Copenhagen University Hospital, Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

  • Hong Kong Children's Hospital

    RECRUITING

    Kowloon Bay, Hong Kong

  • Hospital de Especialidades Pediátricas

    RECRUITING

    Chiapas, Mexico

  • Hôtel-Dieu de France University Medical Center

    RECRUITING

    Beirut, Lebanon

  • Koç University

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Lille University Hospital

    RECRUITING

    Lille, France

  • Madinah Cardiac Center MC

    RECRUITING

    Madinah, Saudi Arabia

  • Magdi Yacoub Heart Foundation

    RECRUITING

    Cairo, Egypt

  • Marie Lannelongue Hospital

    RECRUITING

    Le Plessis-Robinson, France

  • National Cardiovascular Center of Harapan Kita

    RECRUITING

    Jakarta, Indonesia

  • Prince of Songkla University

    RECRUITING

    Songkhla, Thailand

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Queen Sirikit National Institute of Child Health

    RECRUITING

    Nonthaburi, Thailand

  • Rajaie Cardiovascular, Medical and Research Center

    RECRUITING

    Tehran, Iran

  • SBU Tepecik Training and Research Hospital

    RECRUITING

    Izmir, Turkey (Türkiye)

  • Silesian Center for Heart Diseases

    RECRUITING

    Zabrze, Poland

  • Skane University Hospital

    RECRUITING

    Skåne, Sweden

  • The Children's Hospital

    ENROLLING_BY_INVITATION

    Lahore, Pakistan

  • Toulouse University Hospital

    RECRUITING

    Toulouse, France

  • Umraniye Training and Education Hospital

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • University Children's Hospital

    RECRUITING

    Tübingen, Germany

  • University Children's Hospital of Zurich

    RECRUITING

    Zurich, Switzerland

  • University Hospital of Bordeaux

    ENROLLING_BY_INVITATION

    Bordeaux, France

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