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New heart valve could spare congenital patients from repeat surgeries

NCT ID NCT04860765

Disease control Sponsor: Edwards Lifesciences 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new heart valve, called the SAPIEN 3, in 150 people with congenital heart defects whose existing heart valves are not working properly. The valve is placed using a thin tube (catheter) through a blood vessel, avoiding open-heart surgery. The goal is to see if the valve works well and improves blood flow from the heart to the lungs.

What this could mean

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

Active substance
SAPIEN 3 Transcatheter Heart Valve (a replacement heart valve delivered through a catheter)
What this could lead to
If successful, this could offer a less invasive way to replace a faulty heart valve in people with congenital heart disease, potentially avoiding repeat open-heart surgeries.
What could go wrong
This is a post-approval study, so the device is already in use, but long-term outcomes are still being tracked. Risks include blood clots, infection, or the valve not working as well as hoped.

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

150 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Aug 2030

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

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention

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: 1. Dysfunctional RVOT conduit or previously implanted surgical valve 2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg Exclusion Criteria: 1. Inability to tolerate an anticoagulation/antiplatelet regimen 2. Active bacterial endocarditis or other active infections

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Conditions

The condition(s) this trial relates to.

Bites and Stings congenital heart disease pulmonary valve insufficiency pulmonary valve stenosis pulmonic stenosis

As listed by the trial registrant

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

Complex congenital heart defect Dysfunctional rvot conduit Pulmonary valve degeneration Pulmonary valve insufficiency Pulmonary valve; obstruction

Contacts and locations

Locations

  • Advocate Childrens Hospital

    Oak Lawn, Illinois, 60453, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Cedars Sinai

    Los Angeles, California, 90048, United States

  • Children's Health Dallas

    Dallas, Texas, 75235, United States

  • Children's Hospital of Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinatti Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Columbia University Medical Center/NYPH

    New York, New York, 10032, United States

  • Dell Children's

    Austin, Texas, 78723, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Minneapolis Heart

    Minneapolis, Minnesota, 55407, United States

  • Mount Sinai

    New York, New York, 10029, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43215, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • Primary Children's

    Salt Lake City, Utah, 84108, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • University of Alabama

    Birmingham, Alabama, 35487, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 19146, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

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