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New heart valve trial offers hope for patients with rare congenital defects

NCT ID NCT02744677

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study is testing a new heart valve (SAPIEN 3) in 108 people who have a dysfunctional right ventricle outflow tract (RVOT) due to a congenital heart defect or a previous valve replacement. The goal is to see if the valve is safe and effective at improving blood flow and reducing leakage. Participants must be at least 20 kg and have a specific landing zone size for the valve.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 108 people

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

Started

Jul 2016

Expected to finish

Jun 2031

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.

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. Weight ≥ 20 kg (44 lbs.) 2. Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use 3. Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg. 4. The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics) 2. History of or active endocarditis (active treatment with antibiotics) within the past 180 days 3. Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder 4. Inappropriate anatomy for femoral introduction and delivery of the study valve 5. Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty 6. Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI) 7. Interventional/surgical procedures within 30 days prior to the TPVI procedure. 8. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure. 9. History of or current intravenous drug use 10. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year 11. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications 12. Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated 13. Participating in another investigational drug or device study that has not reached its primary endpoint. 14. Female who is lactating or pregnant

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease congenital heart disease persistent truncus arteriosus Pulmonary Atresia pulmonary valve insufficiency pulmonary valve stenosis tetralogy of fallot transposition of the great arteries

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

How to take part

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

  1. The places running it

    21 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

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Health System of Texas / UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235, United States

  • Childrens Hospital of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Cincinnati Children's Hospital

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Columbia University Medical Center/NYPH

    RECRUITING

    New York, New York, 10032, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University/Children's Healthcare of Atlanta

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Intermountain Heart Institute (IMC)

    RECRUITING

    Murray, Utah, 84107, United States

  • LeBonheur Children's Hopsital

    RECRUITING

    Memphis, Tennessee, 38103, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical City Dallas

    RECRUITING

    Dallas, Texas, 75230, United States

  • Methodist San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia

    COMPLETED

    Philadelphia, Pennsylvania, 19104, United States

  • St. Louis Children's Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

  • The Lindner Research Center at Christ Hospital

    COMPLETED

    Cincinnati, Ohio, 45219, United States

  • UPMC Children's Hospital of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California, Los Angeles

    COMPLETED

    Los Angeles, California, 90095, United States

  • University of California,, San Francisco (UCSF)

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Kentucky

    WITHDRAWN

    Lexington, Kentucky, 40536, United States

  • University of Virginia (UVA)

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Washington/Seattle Children's Hospital

    COMPLETED

    Seattle, Washington, 98195, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital

    COMPLETED

    St Louis, Missouri, 63110, United States

More trials for these conditions

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