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

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Conditions studied: Severe Aortic Valve Stenosis

In brief

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

Key facts

Study ID

NCT07545369

Run by

Assiut University

People needed

200

Starts

2026-09-12

Expected to finish

2027-12-12

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Assiut University Heart Hospital — Asyut, Assiut Governorate, Egypt

Full record on ClinicalTrials.gov

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