COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Condition(s) studied
Investigational drug(s) / intervention(s)
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position
SAPIEN 3 THV: SAPIEN 3 THV in the pulmonic position
SAPIEN 3 Ultra RESILIA THV: SAPIEN 3 Ultra RESILIA THV in the pulmonic position
Study 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.
Eligibility
Primary outcome measure(s)
- THV dysfunction — 1 year
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
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | Recruiting |
| Arkansas Children's Hospital | Little Rock | Arkansas | Recruiting |
| University of California, Los Angeles | Los Angeles | California | Completed |
| University of California,, San Francisco (UCSF) | San Francisco | California | Recruiting |
| Childrens Hospital of Colorado | Aurora | Colorado | Recruiting |
| Emory University/Children's Healthcare of Atlanta | Atlanta | Georgia | Recruiting |
| University of Kentucky | Lexington | Kentucky | Withdrawn |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Boston Children's Hospital | Boston | Massachusetts | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| St. Louis Children's Hospital | St Louis | Missouri | Recruiting |
| Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital | St Louis | Missouri | Completed |
| Columbia University Medical Center/NYPH | New York | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| The Lindner Research Center at Christ Hospital | Cincinnati | Ohio | Completed |
| Cincinnati Children's Hospital | Cincinnati | Ohio | Recruiting |
| Nationwide Children's Hospital | Columbus | Ohio | Recruiting |
| Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | Completed |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | Recruiting |
| LeBonheur Children's Hopsital | Memphis | Tennessee | Recruiting |
| Vanderbilt University | Nashville | Tennessee | Recruiting |
| Medical City Dallas | Dallas | Texas | Recruiting |
| Children's Health System of Texas / UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| Methodist San Antonio | San Antonio | Texas | Recruiting |
| Intermountain Heart Institute (IMC) | Murray | Utah | Recruiting |
| University of Virginia (UVA) | Charlottesville | Virginia | Recruiting |
| University of Washington/Seattle Children's Hospital | Seattle | Washington | Completed |
More Edwards Lifesciences trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02744677 on ClinicalTrials.gov ↗ ← All trials in the USA