ALTERRA Post-Approval Study

ID#: NCT05378386

Age: Birth - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: May 12, 2022

End Date: December 01, 2034

Contact Information:
Edwards THV Clinical Affairs
949-250-2500
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:

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
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