Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New device offers hope for heart defect patients with failing circulation

NCT ID NCT07532369

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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a device called the Occlutech Atrial Flow Regulator (AFR) in 25 people whose Fontan circulation (a surgery for a heart defect) is failing. The goal is to see if the device is safe and works well to create a small hole between heart chambers to improve blood flow. Participants have already received the device through a special FDA program.

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 25 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

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

The study population will include participants with a dysfunctional Fontan circulation who can benefit from the creation, enlargement, or reduction of a fenestration to achieve tolerable systemic venous pressures.

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: * The patient has been treated with an AFR device (attempted or successful) for failing Fontan through the Expanded Access Program of the Food and Drug Administration (FDA). * The candidate/candidate's legal guardian has been informed of the nature of the study, agrees to its provisions and has provided written informed consent unless the site's IRB provided a waiver of consent. Exclusion Criteria: * If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Congenital anomaly are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Congenital Abnormalities univentricular heart

As listed by the trial registrant

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

Congenital anomaly Failure of fontan type circulation Fenestration Univentricular heart

How to take part

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

  1. The places running it

    7 sites. 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

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Cook Children's Health Care System

    Fort Worth, Texas, 76104, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • OSF Healthcare System d/b/a/ Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

  • Rady Children's San Deigo

    San Diego, California, 92123, United States

  • University of Alabama

    Birmingham, Alabama, 35233, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.