Actively Recruiting
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Led by Edwards Lifesciences · Updated on 2026-03-06
108
Participants Needed
25
Research Sites
777 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Weight 20 kg (44 lbs.) or more
- Dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position needing intervention
- Landing zone diameter between 16.5 mm and 29 mm immediately before device insertion
- At least moderate pulmonary regurgitation or mean RVOT gradient of 35 mmHg or higher
- Informed consent provided by the participant or legally authorized representative
You will not qualify if you...
- Active infection requiring antibiotic treatment (temporary illness candidates may qualify 2 weeks after stopping antibiotics)
- History or active endocarditis treated with antibiotics in the past 180 days
- Blood disorders such as leukopenia, anemia, thrombocytopenia, or clotting problems
- Anatomy unsuitable for femoral introduction and delivery of the study valve
- Need for other heart defect closures or interventions besides pulmonary artery stenting or angioplasty
- Angiographic signs of coronary artery compression that would occur with valve implantation
- Interventional or surgical procedures within 30 days before the valve implantation
- Planned surgeries or procedures within 30 days after the valve implantation
- History or current intravenous drug use
- Serious non-heart diseases with life expectancy under one year
- Known allergies to aspirin or heparin that prevent use of other blood-thinning medications
- Known allergies to cobalt-chromium, nickel, or contrast media not manageable with premedication
- Participation in another investigational drug or device study not completed
- Female participants who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
Completed
3
University of California,, San Francisco (UCSF)
San Francisco, California, United States, 94143
Actively Recruiting
4
Childrens Hospital of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Emory University/Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
University of Kentucky
Lexington, Kentucky, United States, 40536
Withdrawn
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
9
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
10
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Washington University Barnes- Jewish Medical/ St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Completed
12
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
13
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
14
The Lindner Research Center at Christ Hospital
Cincinnati, Ohio, United States, 45219
Completed
15
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
16
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
17
Penn Presbyterian Medical Center, University of Pennsylvania/ Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Completed
18
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
19
LeBonheur Children's Hopsital
Memphis, Tennessee, United States, 38103
Actively Recruiting
20
Medical City Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
21
Children's Health System of Texas / UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
22
Methodist San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
23
Intermountain Heart Institute (IMC)
Murray, Utah, United States, 84107
Actively Recruiting
24
University of Virginia (UVA)
Charlottesville, Virginia, United States, 22908
Actively Recruiting
25
University of Washington/Seattle Children's Hospital
Seattle, Washington, United States, 98195
Completed
Research Team
E
Edwards THV Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here