Early Feasibility Study of the MASA Valve for Right Ventricular Outflow Tract Reconstruction in Patients Under 22 Years

What this Trial Is About

This research aims to evaluate the safety and potential benefits of the MASA Valve in children and young adults under 22 years old who require reconstruction of the Right Ventricular Outflow Tract RVOT due to congenital heart conditions such as Pulmonary Stenosis, Tetralogy of Fallot, Truncus Arteriosus, Transposition of Great Vessels, Pulmonary Atresia, or those undergoing the Ross Procedure. This early feasibility study gathers initial data to support future studies or regulatory approval. Participants will receive the MASA Valve, a bi-leaflet pulmonary valved conduit made of ePTFE material with integrated leaflets designed to restore blood flow from the right ventricle to the pulmonary arteries while preventing backflow. The valve is surgically implanted to replace or reconstruct the RVOT, including replacement of dysfunctional pulmonary valves or conduits. This is a single-arm study where all participants undergo implantation with the investigational device. During the study, participants will be monitored over one year with follow-up visits to assess safety and device performance, including freedom from device-related death, explant, reoperation, catheter interventions, endocarditis, thrombus, and major hemorrhage. Researchers will also evaluate valve function, pulmonary regurgitation, pulmonary gradient, and valve failure. Participants must be willing to return for follow-up visits and comply with study procedures throughout the trial period.

MASA Valve Early Feasibility Study