ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

ENVISION is a prospective, multi-center clinical investigation at up to 135 sites globally. The objective of this clinical investigation is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The trial will register subjects in three separate cohorts: (1) a pivotal randomized cohort, (2) a valve-in-valve (ViV) cohort and (3) a bicuspid cohort. The objective of the pivotal randomized cohort is to evaluate the safety and effectiveness of the Navitor TAVI System for treating patients with symptomatic, severe native aortic stenosis who are considered intermediate or low risk for surgical mortality. The Randomization Cohort will enroll approximately 1500 subjects and will be randomized between the Navitor TAVI Implantation System (test arm) and any commercially available transcatheter aortic valve system (CAV) (control arm) in a 1:1 ratio. The ViV cohort will be conducted as a separate prospective, multicenter, open label, two-group registry within the ENVISION IDE trial. A total of 250 subjects deemed to be at high or greater risk for open surgical therapy will be enrolled concurrently across two separate groups: 125 subjects undergoing transcatheter Aortic Valve-in-Surgical Aortic Valve replacement (TAV-in-SAV) and 125 subjects undergoing Transcatheter Aortic Valve-in-Transcatheter Aortic Valve replacement (TAV-in-TAV). The bicuspid cohort will be conducted as a separate, prospective multicenter, open label study within the ENVISION IDE trial. A total of 250 symptomatic, severe aortic stenosis subjects with bicuspid aortic valve anatomy who are deemed suitable for transcatheter aortic valve implantation with a Navitor valve will be enrolled.