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Active Not Recruiting
NCT05378386
ALTERRA Post-Approval Study
Conditions: Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly
Sex: All
Healthy volunteers: No
Enrollment: 150
Sponsor: Edwards Lifesciences
Location: Children's of Alabama Birmingham Alabama
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-approval setting
Eligibility Criteria
Inclusion Criteria:
1. Native or surgically-repaired RVOT with severe PR
2. Clinically indicated for pulmonary valve replacement
3. Planned for treatment with the Alterra prestent and SAPIEN 3 THV
Exclusion Criteria:
1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis or other active infections
Source: ClinicalTrials.gov (NCT05378386). StuddyBuddy aggregates publicly available trial information.
