ALTERRA Post-Approval Study

Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05378386

Enrollment

150

Registered

2022-05-18

Start date

2022-05-12

Completion date

2035-07-31

Last updated

2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Alterra prestent, SAPIEN 3, Pulmonic Delivery System, Transcatheter pulmonary valve replacement, Transcatheter pulmonary valve implantation

Brief 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

Detailed description

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

Interventions

DEVICEEdwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Acute Device Success	24 hours post-procedure	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

Countries

Israel, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026