Tortona

Researchers are comparing the safety and effectiveness of the Myval Transcatheter Heart Valve THV Series with other contemporary valve devices, specifically the Sapien THV Series and Evolut THV Series, in patients with severe symptomatic native aortic valve stenosis. This prospective, randomized, multinational trial aims to determine if the Myval THV Series performs at least as well as these established valves for treating this condition. The study will enroll a total of 768 participants, with equal numbers receiving either the Myval THV or the contemporary valves. Participants will receive heart valve replacements via the transfemoral approach using valves sized appropriately for their anatomy. The Myval THV Series includes several device sizes ranging from 20 mm to 29 mm, while the comparator devices include Sapien and Evolut valves in various sizes. The trial also features a non-randomized nested registry to evaluate extra-large Myval valves 30.5 mm and 32 mm and a lead-in phase where investigators perform initial implantations to ensure protocol adherence before enrolling study subjects. Throughout the study, participants will be closely monitored with assessments of valve safety and effectiveness using criteria defined by the Valve Academic Research Consortium-3 VARC-3. Outcomes measured include mortality, stroke, kidney injury, bleeding, valve function, device success, and quality of life, among others, followed up to 10 years. The study includes detailed safety and efficacy evaluations at multiple time points, including pre-discharge, 30 days, 1 year, and longer-term follow-ups. Participants will undergo clinical evaluations, echocardiography, and quality of life questionnaires during these visits.