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New heart valve system offers hope for patients with leaky pulmonary valves

NCT ID NCT05378386

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at a new device to fix leaky pulmonary valves in people born with heart defects. About 150 people will get the Edwards SAPIEN 3 valve placed inside a special stent. The goal is to see if the valve works well and stays in place without major problems.

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

May 2022

Expected to finish

Jul 2035

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 severe PR who have a native or surgically-repaired RVOT, are clinically indicated for pulmonary valve replacement, and are planned for treatment with the Alterra prestent and SAPIEN 3 THV

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. Native or surgically-repaired RVOT with severe PR 2. Clinically indicated for pulmonary valve replacement 3. Planned for treatment with the Alterra prestent and SAPIEN 3 THV 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.

congenital heart disease pulmonary valve insufficiency tetralogy of fallot

As listed by the trial registrant

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

Complex congenital heart defect Pulmonary regurgitation Pulmonary valve insufficiency Rvot anomaly Tetralogy of fallot

Contacts and locations

Locations

  • Advocate Children's Hospital

    Oak Lawn, Illinois, 60453, United States

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Children's Memorial Hermann Hospital

    Houston, Texas, 77030, United States

  • Children's of Alabama

    Birmingham, Alabama, 35233, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Colorado Children's Hospital

    Aurora, Colorado, 80045, United States

  • Columbia University

    New York, New York, 10032, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Le Bonheur Children's Hospital

    Memphis, Tennessee, 38103, United States

  • Medical City Dallas

    Dallas, Texas, 75230, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113, United States

  • Rady Children's Hospital

    San Diego, California, 92123, United States

  • Schneider Children's Medical Center of Israel

    Petah Tikva, Israel

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • St. Joseph's Children's Hospital

    Tampa, Florida, 33607, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • UF Health Shands Hospital

    Gainesville, Florida, 32669, United States

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63130, United States

More trials for these conditions

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