Clinical Trial

Harmony TPV Post-Approval Study

Name: Harmony TPV Post-Approval Study — clinical trial record (NCT05077774)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Active, Not Recruiting

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Summary

The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.

Protocol Amendment History 1 change

notable Enrollment increased: 150 -> 174 participants 2026-06-03

Trial Details

NCT Number	NCT05077774
Lead Sponsor	Medtronic Cardiovascular
Conditions	Congenital Heart Disease, Tetrology of Fallot, RVOT Anomaly, Pulmonary Regurgitation
Enrollment	174 participants
Start Date	2021-10-25
Primary Completion	2026-08 (estimated)
Study Completion	2035-03 (estimated)
Updated on ClinicalTrials.gov	2026-06-02