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Testing the SAPIEN 3 heart valve for a failing pulmonary valve or conduit

Tests SAPIEN 3 replacement heart valves in people with pulmonary valve problems.

Key facts

Who runs it
Edwards Lifesciences
Where
Atlanta, Aurora, Birmingham, Boston, Charlottesville, Cincinnati, Columbus, Dallas, Durham, Lexington, Little Rock, Los Angeles, Memphis, Murray, Nashville, New York, Philadelphia, Pittsburgh, Rochester, San Antonio, San Francisco, Seattle, and St Louis, United StatesSee the 27 sites
Trial code
Registry title
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Status
Recruiting
People taking part
108 people, planned
Started
5 Jul 2016
Expected to end
Jun 2031
Type of study
Interventional, 3 groups
Treatments tested
  • SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
  • SAPIEN 3 THV
  • SAPIEN 3 Ultra RESILIA THV
Record updated
23 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people whose pulmonary valve (the heart valve to the lungs) or RVOT conduit (a tube from the heart's right lower chamber) no longer works well and needs treatment. They get a new valve, the SAPIEN 3 or SAPIEN 3 Ultra RESILIA, placed through a blood vessel.

Sex
All sexes can join.
Disease stage
A poorly working RVOT conduit or earlier implanted valve in the pulmonary position that needs treatment. The landing zone must be ≥ 16.5 mm and ≤ 29 mm wide. At least moderate valve leak (PR) and/or a mean RVOT gradient ≥ 35 mmHg. Weight ≥ 20 kg (44 lbs.).
Earlier treatment
People must already have an RVOT conduit or a valve implanted in the pulmonary position. No heart procedures or surgery in the 30 days before the valve procedure.

Main reasons for not taking part

  • Active infection needing antibiotics, or endocarditis (heart infection) in the past 180 days
  • Low white cells, low red cells, low platelets or any known blood clotting disorder
  • Body shape that does not allow the valve to be placed through the groin vein, or risk of pressing on the heart arteries
  • Past or current intravenous drug use
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Weight ≥ 20 kg (44 lbs.)
  • 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
  • Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg
  • 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

Who cannot take part

  • History of or active endocarditis (active treatment with antibiotics) within the past 180 days
  • 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
  • Interventional/surgical procedures within 30 days prior to the TPVI procedure
  • Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure
  • Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
  • Participating in another investigational drug or device study that has not reached its primary endpoint
  • Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
  • Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
  • History of or current intravenous drug use
  • Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
  • Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
  • Inappropriate anatomy for femoral introduction and delivery of the study valve
  • Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
  • Female who is lactating or pregnant

Where in United States

  • Emory University, Children's Healthcare of AtlantaAtlanta, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Childrens Hospital of ColoradoAurora, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University of Alabama at BirminghamBirmingham, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Boston Children's HospitalBoston, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Massachusetts General HospitalBoston, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University of Virginia (UVA)Charlottesville, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Cincinnati Children's HospitalCincinnati, United StatesContact: Edwards THV Clinical AffairsTaking people
  • The Lindner Research Center at Christ HospitalCincinnati, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Nationwide Children's HospitalColumbus, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Children's Health System of Texas / UT Southwestern Medical CenterDallas, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Medical City DallasDallas, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Duke University Medical CenterDurham, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University of KentuckyLexington, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • Arkansas Children's HospitalLittle Rock, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University of California, Los AngelesLos Angeles, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • LeBonheur Children's HopsitalMemphis, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Intermountain Heart Institute (IMC)Murray, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Vanderbilt UniversityNashville, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Columbia University Medical Center/NYPHNew York, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • UPMC Children's Hospital of PittsburghPittsburgh, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Mayo Clinic - RochesterRochester, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Methodist San AntonioSan Antonio, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University of California, San Francisco (UCSF)San Francisco, United StatesContact: Edwards THV Clinical AffairsTaking people
  • University of Washington - Seattle Children's HospitalSeattle, United StatesContact: Edwards THV Clinical AffairsNo longer taking part
  • St. Louis Children's HospitalSt Louis, United StatesContact: Edwards THV Clinical AffairsTaking people
  • Washington University Barnes- Jewish Medical/ St. Louis Children's HospitalSt Louis, United StatesContact: Edwards THV Clinical AffairsNo longer taking part

About the trial

What the trial wants to find out

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

The 3 groups in the trial

  • TPVR - Main CohortTreatment being tested

    Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

    Treatment: SAPIEN 3 THV

  • TPVR - THV RegistryTreatment being tested

    Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.

    Treatment: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV

  • TPVR- S3UR RegistryTreatment being tested

    Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

    Treatment: SAPIEN 3 Ultra RESILIA THV

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
Plain-language title
Testing the SAPIEN 3 heart valve for a failing pulmonary valve or conduitGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
23 July 2026