Comparing Myval Balloon-Expandable Valve and Surgical Valve Replacement for Severe Aortic Stenosis in Patients Aged 65 to 75

What this Trial Is About

This research aims to compare the clinical outcomes of the Myval balloon-expandable transcatheter heart valve THV series with those of surgical bioprosthetic aortic valve replacement SAVR in patients aged 65 to 75 years who have symptomatic severe aortic stenosis. The study is a prospective, randomized, multinational, multicenter, open-label trial including 1180 participants. It assesses whether the Myval THV is not worse than SAVR regarding safety and effectiveness. Participants are randomly assigned to receive either the Myval balloon-expandable THV or a surgical bioprosthetic valve available at the clinical site. The procedures involve either transcatheter aortic valve replacement TAVR using the Myval device or standard surgical aortic valve replacement SAVR. The study includes a CT scan sub-study at selected sites to evaluate the feasibility of valve re-interventions and valve performance. During the study, participants will be monitored for safety and efficacy outcomes including death, stroke, bleeding, kidney injury, rehospitalization, and valve function over periods ranging from 1 month to up to 10 years. Assessments include clinical evaluations, transthoracic echocardiograms, CT scans, and recording of adverse events. The research team will track valve hemodynamics, complications, and the need for interventions to understand long-term results and safety.

Surgical vs Transcatheter Aortic Valve Replacement in YOUNG Patients