COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Key facts
- 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
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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Edwards Lifesciences
- Trial code
- NCT02744677
- Record updated
- 23 July 2026
- Original description
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.Read full original descriptionShow less
COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
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.
Inclusion: 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.
Exclusion: 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.