Tortona

Researchers are evaluating the safety and effectiveness of the Myval Transcatheter Heart Valve (THV) Series compared to Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis. This prospective, randomized, multinational, and open-label trial involves 768 participants, evenly divided between the two treatment groups, using a transfemoral approach for valve replacement. Participants will receive either the Myval THV Series or one of the Contemporary Valves, with device sizes ranging from 20 mm to 29 mm for Myval and Sapien series, and 23 mm to 34 mm for the Evolut series. The study includes non-randomized registries for patients requiring extra-large Myval valve sizes and for initial lead-in cases performed under guidance before randomization. Throughout the study, participants will be monitored for safety and effectiveness outcomes, including the Primary Combined Safety and Effectiveness Endpoint defined by the Valve Academic Research Consortium-3 within 30 days post-procedure. Researchers will assess valve function and patient health to compare the performance of the devices, with follow-up evaluations conducted to ensure thorough safety monitoring.