Status:
ACTIVE_NOT_RECRUITING
ALTERRA Post-Approval Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Pulmonary Valve Insufficiency
Complex Congenital Heart Defect
Eligibility:
All Genders
Brief Summary
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-appr...
Detailed Description
This is a single arm, prospective, multicenter post-approval study.
Eligibility Criteria
Inclusion
- Native or surgically-repaired RVOT with severe PR
- Clinically indicated for pulmonary valve replacement
- Planned for treatment with the Alterra prestent and SAPIEN 3 THV
Exclusion
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis or other active infections
Key Trial Info
Start Date :
May 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2035
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05378386
Start Date
May 12 2022
End Date
July 1 2035
Last Update
November 4 2025
Active Locations (24)
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1
Children's of Alabama
Birmingham, Alabama, United States, 35233
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
4
Rady Children's Hospital
San Diego, California, United States, 92123