Status:
ACTIVE_NOT_RECRUITING
COMPASSION S3 Post-Approval Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Complex Congenital Heart Defect
Dysfunctional RVOT Conduit
Eligibility:
All Genders
Brief Summary
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 previo...
Detailed Description
This is a single arm, prospective, multicenter post-approval study.
Eligibility Criteria
Inclusion
- Dysfunctional RVOT conduit or previously implanted surgical valve
- RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg
Exclusion
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis or other active infections
Key Trial Info
Start Date :
April 13 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2030
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04860765
Start Date
April 13 2021
End Date
August 1 2030
Last Update
February 4 2025
Active Locations (19)
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1
University of Alabama
Birmingham, Alabama, United States, 35487
2
Cedars Sinai
Los Angeles, California, United States, 90048
3
Children's Hospital of Colorado
Aurora, Colorado, United States, 80045
4
Advocate Childrens Hospital
Oak Lawn, Illinois, United States, 60453