ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves
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- Who runs it
- Assiut University
- Trial code
- NCT07545369
- Record updated
- 22 April 2026
- Original description
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The ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves
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
Inclusion: Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm², mean transvalvular gradient ≥40 mmHg, or peak transvalvular velocity ≥4.0 m/s; Symptomatic with New York Heart Association (NYHA) functional class II, III, or IV; Heart team consensus that transcatheter aortic valve implantation (TAVI) is the appropriate treatment strategy; Anatomically suitable for both valve types (SAPIEN 3 Ultra Resilia and Evolut FX) as determined by pre-procedural computed tomography (CT) imaging; Age ≥18 years; Able and willing to provide written informed consent; Able and willing to comply with all scheduled follow-up visits and assessments.
Exclusion: Prior surgical or transcatheter aortic valve replacement; Contraindication to dual antiplatelet therapy or anticoagulation; Estimated life expectancy less than 1 year due to non-cardiac comorbidities; Bicuspid aortic valve morphology; Severe mitral regurgitation or severe tricuspid regurgitation requiring intervention; Active infective endocarditis; Pregnancy or breastfeeding.