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ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves
Sponsor: Assiut University
Summary
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
Official title: The ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-09-12
Completion Date
2027-12-12
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
SAPIEN 3 Ultra Resilia
Balloon-expandable transcatheter aortic valve featuring anti-calcification tissue treatment. Delivered via transcatheter approach (typically transfemoral) under fluoroscopic guidance. Valve sizes available include 20 mm, 23 mm, 26 mm, and 29 mm.
Evolut FX
Self-expanding transcatheter aortic valve with enhanced radial strength and conformability. Features a recapturable and repositionable delivery system. Delivered via transcatheter approach (typically transfemoral). Valve sizes available include 23 mm, 26 mm, 29 mm, and 34 mm.
Locations (1)
Assiut University Heart Hospital
Asyut, Assiut Governorate, Egypt