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New heart valve fix could spare thousands from Open-Heart surgery

NCT ID NCT03130777

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new device (Alterra Prestent) used with a replacement heart valve (SAPIEN 3) to fix a leaky pulmonary valve in people born with heart defects. About 86 participants with moderate or severe leakage will get the device through a tube in a blood vessel, avoiding open-heart surgery. The goal is to see if the valve works well and stays in place, reducing leakage and improving heart function.

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

86 people

The number who actually took part.

Started

Aug 2017

Expected to finish

Jun 2032

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. The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. 2. Weight is ≥ 20 kg (44 lbs). 3. RVOT/PV with moderate or greater PR by TTE. 4. RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff. Exclusion Criteria: 1. Active infection requiring current antibiotic therapy (if temporary illness, patient 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 (WBC \< 2000 cells/μL), anemia (Hgb \< 7 g/dL), thrombocytopenia (platelets \< 50,000 cells/μL) or any known blood clotting disorder. 4. Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV. 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. Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure 7. Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure 8. History of or current intravenous drug use 9. Major or progressive non-cardiac disease resulting in a life expectancy of less than one year 10. Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications 11. Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated 12. Currently participating in an investigational drug or another device study \[Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.\] 13. Positive urine or serum pregnancy test in female patients of child-bearing potential 14. Renal insufficiency (creatinine \> 3.0 mg/dL) and/or renal replacement therapy

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Conditions

The condition(s) this trial relates to.

congenital heart disease lung disorder pulmonary valve insufficiency tetralogy of fallot

As listed by the trial registrant

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

Congenital heart disease Pulmonary disease Pulmonary regurgitation Tetralogy of fallot Transcatheter pulmonary valve replacement (TPVR)

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Children's Health Dallas

    Dallas, Texas, 75235, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati Children's Hospital

    Cincinnati, Ohio, 45229, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Emory University/ Children's Healthcare of Atlanta (CHOA)

    Atlanta, Georgia, 30322, United States

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110, United States

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • University of California, Los Angeles

    Los Angeles, California, 90095, United States

  • University of California, San Francisco

    San Francisco, California, 94122, United States

  • University of Virgina

    Charlottesville, Virginia, 22908, United States

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