ALTERRA Post-Approval Study

Launched by EDWARDS LIFESCIENCES · May 12, 2022

Keywords

ClinConnect Summary

The ALTERRA Post-Approval Study is designed to evaluate how well a new heart device, called the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent, works in patients who need treatment for certain heart conditions. These conditions include issues like pulmonary valve insufficiency, which means the valve isn't working properly, and other complex congenital heart defects. The study is currently looking for participants of all ages who have severe pulmonary regurgitation (PR) and are recommended for surgery to replace their pulmonary valve.

To be eligible for the study, participants should either have a native or surgically repaired right ventricular outflow tract (RVOT) and have a strong need for a new valve. However, individuals who cannot safely take blood-thinning medications or have active infections are excluded from participating. If you join the study, you can expect to undergo the implantation of the new device and be monitored to see how well it performs and how it affects your health moving forward. This research aims to help doctors better understand the benefits and outcomes of this new treatment option for patients with heart issues.

Gender

ALL

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