Global Study Evaluating Safety and Performance of Navitor Transcatheter Aortic Valve Replacement System in Aortic Stenosis

What this Trial Is About

The VISTA Nova Study focuses on patients with aortic stenosis who are undergoing transcatheter aortic valve replacement TAVR. The goal is to assess the safety, performance, and long-term durability of the Navitor valve in a real-world setting. This observational study evaluates how well the device works and its impact on patient outcomes over time. Participants will receive the Navitor Transcatheter Aortic Valve using the FlexNav delivery system and the Navitor Loading System. The Navitor valve comes in five sizes to fit annulus diameters from 19 mm to 30 mm, and the delivery and loading systems are available in two sizes each. The procedure follows approved indications and involves specialized equipment to implant the valve. During the study, participants will be monitored at scheduled follow-up visits after their TAVI procedure to track outcomes such as overall survival and valve leakage. The primary outcomes measured include all-cause mortality and the presence of moderate or greater paravalvular leak at 30 days post-procedure. Participants are expected to return for all required follow-up visits to help researchers evaluate the valves long-term safety and effectiveness, with the study continuing through 2032.

Post-Market Clinical Follow Up Study With Navitor Valve