U.S., April 3 -- ClinicalTrials.gov registry received information related to the study (NCT06906926) titled 'Harmony TPV EMEA PMS' on March 26.
Brief 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.
Study Start Date: April 01
Study Type: INTERVENTIONAL
Condition: ...