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A tiny plug in the lung arteries may offer a gentler path for children with heart defects

NCT ID NCT07791069

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 trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This international registry study looks at a small device called a transcatheter pulmonary flow restrictor, which doctors implant in the lung arteries of young children with congenital or acquired heart disease. The goal is to see whether the device safely and effectively controls blood flow to the lungs, potentially improving outcomes and reducing the need for more invasive procedures. Researchers will track 150 patients up to age 3 who received the device between 2019 and 2028, measuring technical success, clinical benefit, and any major complications.

What this could mean

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

Active substance
Transcatheter pulmonary flow restrictor, a small device implanted in the lung arteries to control blood flow
What this could lead to
If successful, this approach could offer a less invasive way to manage blood flow in children with heart disease, potentially delaying or avoiding more complex surgeries.
What could go wrong
This is an observational registry, not a controlled trial, so results may vary across centers. The device carries risks such as migration, vessel damage, or incomplete flow restriction.

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 150 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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

Pediatric patients (≤3 years) with any congenital or acquired heart disease, regardless of gender, ethnicity, or geographic location, who underwent transcatheter insertion of the MVP-based PFR device in single or bilateral PA branches between January 2019 and January 2028.

Ages

Up to 3 years

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: * Pediatric patients (≤3 years) with any congenital or acquired heart disease, regardless of gender, ethnicity, or geographic location, who underwent transcatheter insertion of the MVP-based PFR device in single or bilateral PA branches between January 2019 and January 2028. * Informed consent obtained from parents or legal guardians. Exclusion Criteria: * Study device implanted in other locations: modified BT shunt, arterial duct, stented arterial duct, Sano conduit, and central shunt.

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Conditions

The condition(s) this trial relates to.

congenital heart disease heart disorder

As listed by the trial registrant

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

Congenital heart disease

How to take part

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

  1. The places running it

    4 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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 Specialty Hospital

    Dubai, United Arab Emirates

  • Leeds Teaching Hospitals NHS Trust

    Leeds, United Kingdom

  • Marie Lannelongue Hospital

    Le Plessis-Robinson, France

  • Mother and Child Health Institute of Serbia

    Belgrade, Serbia

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