At a glance
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Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study
In Brief
A clinical study evaluating Transcatheter Pulmonary Valve replacement for Congenital Heart Defects and Dysfunctional Right Ventricular Outflow Tract Conduits. Completed, enrolled 171 participants across 5 sites.
Detailed Summary
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.
Study Details
Timeline
Interventions
Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.