This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3/SAPIEN 3 Ultra THV or Clinical Surveillance.
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis.