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

Observational


Primary Outcome

Acute Device Success


Condition

Pulmonary Valve Insufficiency

Intervention

Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

Study Arms / Comparison Groups

 TPVR
Description:  Transcatheter Pulmonary Valve Replacement

Publications

* 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

Device

Estimated Enrollment

150

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, 949-250-2500, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05378386

Organization ID

2021-11


Responsible Party

Sponsor

Study Sponsor

Edwards Lifesciences


Study Sponsor

, , 


Verification Date

June 2022