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ALTERRA Post-Approval Study

Recruiting
years of age
Both
Phase N/A
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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

Description

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

Eligibility

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

Study details

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

NCT05378386

Edwards Lifesciences

20 March 2024

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