The purpose of this study is to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with the Alterra Adaptive Prestent, which is approved by the U.S. Food and Drug Administration. The combined devices will be used to prevent the backflow of blood (pulmonary regurgitation) across the right ventricular outflow tract (RVOT). The RVOT is the area that connects one of the pumping chambers of the heart (the right ventricle) to the main artery supplying blood flow to the lungs (the main pulmonary artery). The study focuses on individuals whose RVOT has a large amount of regurgitation and needs a valve placed within it. To allow for adequate placement of the pulmonary valve, a prestent needs to be placed first to reconfigure the RVOT in these patients.
The SAPIEN 3 Transcatheter Pulmonary Valve System with the Alterra Adaptive Prestent uses a different procedure that does not involve open-heart surgery. The prestent is an expandable metal mesh and cloth tube that will anchor to the walls of the RVOT, thereby reshaping it internally so that a transcatheter pulmonary valve may be placed.
Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent