COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Start Date
7/5/2016
Completion Date
6/1/2031
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 Criteria
Age Range: No minimum to No maximum
Interventions
SAPIEN 3/SAPIEN 3 Ultra RESILIA THV
SAPIEN 3 THV
SAPIEN 3 Ultra RESILIA THV
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35233
United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United States
University of California, Los Angeles
Los Angeles, California 90095
United States
University of California,, San Francisco (UCSF)
San Francisco, California 94143
United States
Childrens Hospital of Colorado
Aurora, Colorado 80045
United States
Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia 30322
United States
University of Kentucky
Lexington, Kentucky 40536
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
Mayo Clinic Rochester
Rochester, Minnesota 55905
United States
St. Louis Children's Hospital
St Louis, Missouri 63110
United States
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
St Louis, Missouri 63110
United States
Columbia University Medical Center/NYPH
New York, New York 10032
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
The Lindner Research Center at Christ Hospital
Cincinnati, Ohio 45219
United States
Cincinnati Children's Hospital
Cincinnati, Ohio 45229
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
United States
LeBonheur Children's Hopsital
Memphis, Tennessee 38103
United States
Vanderbilt University
Nashville, Tennessee 37232
United States
Medical City Dallas
Dallas, Texas 75230
United States
Children's Health System of Texas / UT Southwestern Medical Center
Dallas, Texas 75235
United States
Methodist San Antonio
San Antonio, Texas 78229
United States
Intermountain Heart Institute (IMC)
Murray, Utah 84107
United States
University of Virginia (UVA)
Charlottesville, Virginia 22908
United States
University of Washington/Seattle Children's Hospital
Seattle, Washington 98195
United States