Congenital Pulmonic Valve Dysfunction Treated With SAPIEN 3 Transcatheter Heart Valve (from the COMPASSION S3 Trial).
D Scott Lim, Dennis Kim, Jamil Aboulhosn...
https://pubmed.ncbi.nlm.nih.gov/36608435Actively Recruiting
Phase Not Applicable
All Genders
ID02744677
COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
Led by Edwards Lifesciences · Updated on 2026-03-06
108
Participants Needed
25
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in patients who have a dysfunctional right ventricular outflow tract (RVOT) conduit or a previously implanted valve in the pulmonic position that requires medical intervention. This study focuses on those with pulmonary valve dysfunction, a complex congenital heart defect, pulmonary valve insufficiency, or pulmonary valve degeneration. Participants will undergo transcatheter pulmonary valve replacement (TPVR) using either the SAPIEN 3 or SAPIEN 3 Ultra RESILIA THV devices placed in the pulmonic position. The study includes different groups based on valve type and prior valve implantation status. The procedure is designed as a non-randomized intervention. During the study, participants will be closely monitored for valve function and potential complications. Assessments include measuring THV dysfunction at one year, device success shortly after discharge, heart function and valve performance at six months, and safety events such as vascular complications, bleeding, infection, and mortality within one year. Study involvement may last up to one year with regular follow-up visits for evaluations and safety monitoring.
CONDITIONS
Brief Title
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Weight of at least 20 kg (44 lbs.)
- Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position needing intervention with a landing zone diameter between 16.5 mm and 29 mm
- At least moderate pulmonary regurgitation (PR) and/or mean RVOT gradient of 35 mmHg or higher
- Provided informed consent to participate in the study
You will not qualify if you...
- Active infection requiring antibiotics or endocarditis within the past 180 days
- Blood disorders such as leukopenia, anemia, thrombocytopenia, or clotting problems
- Anatomy unsuitable for femoral introduction of the study valve
- Need for other heart defect closures or interventional procedures besides pulmonary artery stenting or angioplasty
- Coronary artery compression risk from valve implantation
- Recent interventional or surgical procedures within 30 days before the valve implantation
- Planned procedures within 30 days after valve implantation
- History or current intravenous drug use
- Severe non-cardiac disease with life expectancy under one year
- Known allergies to aspirin, heparin, cobalt-chromium, nickel, or contrast media that cannot be managed
- Participation in other investigational drug or device studies not yet completed
- Female participants who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure and hospital stay expected within 1 to 5 days post-procedure
Participants undergo transcatheter pulmonary valve replacement (TPVR) using the SAPIEN 3/SAPIEN 3 Ultra RESILIA transcatheter heart valve in the pulmonic position.
1 procedure visit and hospitalization
Post-operative Follow-up
Duration - Up to 1 year
Participants are monitored for valve function, complications, and overall health after the procedure.
Visits at 30 days, 6 months, and 1 year post-procedure
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
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Research Team
E
Edwards THV Clinical Affairs
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Five-Year Outcomes for Patients With RVOT Dysfunction Treated With the SAPIEN 3 Transcatheter Heart Valve: A Pooled Analysis From the COMPASSION S3 Trial.
Michael R Hainstock, Gregory Fleming, Dennis Kim...
https://pubmed.ncbi.nlm.nih.gov/41884901