ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves
TAVR
The ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves
1 other identifier
interventional
200
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 22, 2026
CompletedStudy Start
First participant enrolled
September 12, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2027
Study Completion
Last participant's last visit for all outcomes
December 12, 2027
April 22, 2026
April 1, 2026
1 year
April 16, 2026
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Device Success Rate at 30 Days
Composite endpoint defined according to Valve Academic Research Consortium-3 (VARC-3) criteria, including: absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, absence of moderate or severe prosthetic valve regurgitation (paravalvular or central), and acceptable hemodynamic performance (mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s)
30 days post-procedure
Secondary Outcomes (1)
Mean Aortic Valve Gradient
3 months post-procedure
Study Arms (2)
SAPIEN 3 Ultra Resilia
ACTIVE COMPARATORBalloon-expandable transcatheter aortic valve with anti-calcification tissue treatment.
Evolut FX
ACTIVE COMPARATORSelf-expanding transcatheter aortic valve with enhanced radial strength and conformability.
Interventions
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.
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University Heart Hospital
Asyut, Assiut Governorate, 71515, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
April 16, 2026
First Posted
April 22, 2026
Study Start (Estimated)
September 12, 2026
Primary Completion (Estimated)
September 12, 2027
Study Completion (Estimated)
December 12, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share