ALTERRA Post-Approval Study

N/AActive Not RecruitingNCT05378386

Edwards Lifesciences150 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

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

Interventions

Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve SystemDEVICE

The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular right ventricular outflow tracts (RVOTs) and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 transcatheter heart valve (THV).

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (24)

Children's of Alabama

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Acute Device Success

Acute Device Success, defined as a non-hierarchical composite of: * Single Alterra deployed in the desired location * Single THV implanted in the desired location within Alterra * Right ventricle-pulmonary artery peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram * Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation

Time frame: 24 hours post-procedure

Data from ClinicalTrials.gov

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