Harmony TPV EMEA PMS
Harmony TPV EMEA Post-Market Study
Medtronic Cardiovascular
80 participants
Jul 30, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Pre-Implant CT, Chest X-Ray at discharge and any related assessments during the following up visit, can be non-standard of care depending on site's / countries.
Locations(12)
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NCT06906926