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ALTERRA Post-Approval Study | Clinical Trials | Clareo Health

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Active Not RecruitingNCT05378386

ALTERRA Post-Approval Study

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-appr...

Lead sponsor: Edwards Lifesciences•23 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Edwards Lifesciences

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

Age

All ages

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 4, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

Phase—

Enrollment150

Start dateMay 2022

Last updatedNov 4, 2025

Condition

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

Locations shown

Children's of Alabama

Birmingham, Alabama

Arkansas Children's Hospital

Little Rock, Arkansas

Cedars Sinai Medical Center

Los Angeles, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2025Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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