Active — Not RecruitingNot Applicable

ALTERRA Post-Approval Study

United States150 participantsStarted 2022-05-12

Plain-language 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

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. Inability to tolerate an anticoagulation/antiplatelet regimen
✕. Active bacterial endocarditis or other active infections

What they're measuring

Acute Device Success

Timeframe: 24 hours post-procedure

Trial details

NCT IDNCT05378386

SponsorEdwards Lifesciences

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-09-25

View on ClinicalTrials.gov More Pulmonary Valve Insufficiency trials