ALTERRA Post-Approval Study

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Brief Title

ALTERRA Post-Approval Study

Official Title

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

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.

Study Type


Primary Outcome

Acute Device Success


Pulmonary Valve Insufficiency


Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

Study Arms / Comparison Groups

Description:  Transcatheter Pulmonary Valve Replacement


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

May 12, 2022

Completion Date

December 2034

Primary Completion Date

December 2024

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




N/A - N/A

Accepts Healthy Volunteers



, 949-250-2500, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Edwards Lifesciences

Study Sponsor

, , 

Verification Date

June 2022