Clinical Trial

Harmony TPV EMEA PMS

Recruiting
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Summary
The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2025-03-26; most recent amendment 2026-07-13.
Status change: Not Yet Recruiting → Recruiting 2025-08-01
Trial Details
NCT Number NCT06906926
Lead Sponsor Medtronic Cardiovascular
Conditions Severe Pulmonary Valve Regurgitation
Enrollment 80 participants
Start Date 2025-07-30
Primary Completion 2027-07-31 (estimated)
Study Completion 2032-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-14