COMPASSION S3 Post-Approval Study (NCT04860765)
🩺 Plain-English Summary (8th-Grade Level)
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (3 items).
Location: University of Alabama — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis or other active infections
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (19 Sites)
- University of Alabama — Birmingham, Alabama
- Cedars Sinai — Los Angeles, California
- Children's Hospital of Colorado — Aurora, Colorado
- Advocate Childrens Hospital — Oak Lawn, Illinois
- Boston Children's Hospital — Boston, Massachusetts
- Minneapolis Heart — Minneapolis, Minnesota
- St. Louis Children's Hospital — St Louis, Missouri
- Newark Beth Israel Medical Center — Newark, New Jersey
- Mount Sinai — New York, New York
- Columbia University Medical Center/NYPH — New York, New York
- Duke University — Durham, North Carolina
- Cincinatti Children's Hospital — Cincinnati, Ohio
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Dell Children's — Austin, Texas
- Children's Health Dallas — Dallas, Texas
- Primary Children's — Salt Lake City, Utah
- University of Virginia — Charlottesville, Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.