ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves

簡要摘要

Title: The ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves Brief Summary: The goal of this clinical trial is to compare the latest-generation balloon-expandable (SAPIEN 3 Ultra Resilia) versus self-expanding (Evolut FX) transcatheter aortic valves in patients with severe, symptomatic aortic stenosis who are undergoing transcatheter aortic valve implantation (TAVI). The main questions it aims to answer are: Does device success rate (defined by VARC-3 criteria) at 30 days differ between the SAPIEN 3 Ultra Resilia and the Evolut FX valves? Do hemodynamic performance (mean gradient, effective orifice area) and incidence of moderate/severe paravalvular leak differ between the two valve types at 30 days and 1 year? Researchers will compare patients randomized to receive the SAPIEN 3 Ultra Resilia valve versus patients randomized to receive the Evolut FX valve to see if there are differences in device success, safety outcomes, and valve performance. Participants will: Undergo standard pre-procedural clinical, echocardiographic, and CT assessment Be randomly assigned to receive either the SAPIEN 3 Ultra Resilia or Evolut FX valve during their clinically indicated TAVI procedure Receive post-procedure follow-up assessments including echocardiography and clinical evaluation at 24 hours, 30 days, 6 months, and 1 year