COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
NCT02744677
This study is recruiting at 21 US sites in 16 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Complex Congenital Heart Defect
- Dysfunctional RVOT Conduit
- Pulmonary Valve Insufficiency
- Pulmonary Valve Degeneration
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- Any age
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Edwards Lifesciences
- Last updated on ClinicalTrials.gov
- July 23, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alabama · 1
- University of Alabama at Birmingham · Birmingham, AL
Arkansas · 1
- Arkansas Children's Hospital · Little Rock, AR
California · 1
- University of California,, San Francisco (UCSF) · San Francisco, CA
Colorado · 1
- Childrens Hospital of Colorado · Aurora, CO
Georgia · 1
- Emory University/Children's Healthcare of Atlanta · Atlanta, GA
Massachusetts · 2
- Boston Children's Hospital · Boston, MA
- Massachusetts General Hospital · Boston, MA
Minnesota · 1
- Mayo Clinic Rochester · Rochester, MN
Missouri · 1
- St. Louis Children's Hospital · St Louis, MO
New York · 1
- Columbia University Medical Center/NYPH · New York, NY
North Carolina · 1
- Duke University Medical Center · Durham, NC
Ohio · 2
- Cincinnati Children's Hospital · Cincinnati, OH
- Nationwide Children's Hospital · Columbus, OH
Pennsylvania · 1
- UPMC Children's Hospital of Pittsburgh · Pittsburgh, PA
Tennessee · 2
- LeBonheur Children's Hopsital · Memphis, TN
- Vanderbilt University · Nashville, TN
Texas · 3
- Children's Health System of Texas / UT Southwestern Medical Center · Dallas, TX
- Medical City Dallas · Dallas, TX
- Methodist San Antonio · San Antonio, TX
Utah · 1
- Intermountain Heart Institute (IMC) · Murray, UT
Virginia · 1
- University of Virginia (UVA) · Charlottesville, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.