ALTERRA Post-Approval Study

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Complex Congenital Heart Defect; Pulmonary Regurgitation; Tetralogy of Fallot; RVOT Anomaly; Pulmonary Valve Insufficiency

Treatments: Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

Study type: Observational

Funder types: Industry

Identifiers

NCT05378386

2021-11

Details and patient eligibility

About

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

Full description

This is a single arm, prospective, multicenter post-approval study.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

TPVR

Description:

Transcatheter Pulmonary Valve Replacement

Treatment:

Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System