Not Yet RecruitingNot Applicable

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

Egypt200 participantsStarted 2026-09-12

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * Bicuspid aortic valve morphology * Severe mitral regurgitation or severe tricuspid regurgitation requiring intervention * Prior surgical or transcatheter aortic valve replacement * Active infective endocarditis * Contraindication to dual antiplatelet therapy or anticoagulation * Estimated life expectancy less than 1 year due to non-cardiac comorbidities * Pregnancy or breastfeeding

What they're measuring

Device Success Rate at 30 Days

Timeframe: 30 days post-procedure

Trial details

NCT IDNCT07545369

SponsorAssiut University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-12

Contact for this trial

Ahmed A Hassaan, Assistant Lecturer

+201068115040 ahmed.hassaan1994@aun.edu.eg