Abstract

The Harmony transcatheter pulmonary valve (TPV) is designed to treat severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). Our objective was to evaluate 1-year safety and effectiveness in patients from the Early Feasibility Study (EFS), Harmony TPV Pivotal Study, and Continued Access Study (CAS), representing the largest cohort to date of Harmony TPV recipients.

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