ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves (NCT07545369) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.