COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
AI 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.
- Who can join
- child, adult, older adult
- Participants
- 108
- Expected completion
- 2031-06
- Funded by
- industry
Conditions studied
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Degeneration, Pulmonary Valve Insufficiency
What is being tested
- DEVICE: SAPIEN 3 THV
- DEVICE: SAPIEN 3 Ultra RESILIA THV
- DEVICE: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
What it measures
- THV dysfunction, Defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient \> 40 mmHg via TTE, 1 year
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Arkansas Children’s Hospital
Little Rock, AR
Barnes-Jewish Hospital
Saint Louis, MO
Boston Children's Hospital
Boston, MA
Cincinnati Children's Hospital Medical Center
Cincinnati, OH
Duke University Hospital
Durham, NC
Emory University Hospital
Atlanta, GA
Intermountain Medical Center
Murray, UT
Massachusetts General Hospital
Boston, MA
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
Medical City Heart Hospital (Dallas)
Dallas, TX
Methodist Hospital
San Antonio, TX
Nationwide Children's Hospital
Columbus, OH
Penn Presbyterian Medical Center
Philadelphia, PA
Ronald Reagan UCLA Medical Center
Los Angeles, CA
The Christ Hospital
Cincinnati, OH
UAB Hospital
Birmingham, AL
UCSF Health
San Francisco, CA
UK Albert B. Chandler Hospital
Lexington, KY
University Medical Center
Charlottesville, VA
University of Colorado Hospital
Aurora, CO
University of Washington Medical Center
Seattle, WA
Vanderbilt University Medical Center
Nashville, TN
William P. Clements Jr. University Hospital
Dallas, TX
Registry entry updated 2026-07-23
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.