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Evaluation of a heart valve for patients with pulmonary valve dysfunction

COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

NA · Edwards Lifesciences · NCT02744677

This study tests a new heart valve to see if it can safely help people with problems in their pulmonary valve or right ventricular outflow tract.

Quick facts

PhaseNA
Study typeInterventional
Enrollment108 (estimated)
SexAll
SponsorEdwards Lifesciences (industry)
Locations25 sites (Little Rock, Arkansas and 24 other locations)
Trial IDNCT02744677 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve in patients who have a dysfunctional right ventricular outflow tract conduit or a previously implanted valve in the pulmonic position. Participants must have a clinical indication for intervention and meet specific anatomical criteria for valve insertion. The study aims to provide a less invasive treatment option for patients with complex congenital heart defects and pulmonary valve issues.

Who should consider this trial

Good fit: Ideal candidates are patients weighing at least 20 kg with a dysfunctional RVOT conduit or previously implanted valve and moderate pulmonary regurgitation.

Not a fit: Patients with active infections, certain blood disorders, or inappropriate anatomy for valve delivery may not benefit from this study.

Why it matters

Potential benefit: If successful, this could offer a safer and more effective treatment option for patients with pulmonary valve dysfunction.

How similar studies have performed: Other studies have shown promise with transcatheter heart valves in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Little Rock, Arkansas and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Pulmonary Atresia, Pulmonary Stenosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.