ULTRA-EVOLUT RCT: A Comparison of Latest-Generation TAVR Valves
ConditionSevere Aortic Valve Stenosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Bicuspid aortic valve morphology
Severe mitral regurgitation or severe tricuspid regurgitation requiring intervention
Prior surgical or transcatheter aortic valve replacement
Active infective endocarditis
Trial design
Design model
Parallel
Treatments tested in this trial
SAPIEN 3 Ultra Resilia
DeviceBalloon-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.
Evolut FX
DeviceSelf-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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: SAPIEN 3 Ultra ResiliaActive comparator 1 intervention
Group B: Evolut FXActive comparator 1 intervention
Trial outcomes
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)
Time frame
30 days post-procedureSecondary outcomes
1
Mean Aortic Valve Gradient
Hemodynamic performance assessed by transthoracic echocardiography. Measured as mean transvalvular gradient (mmHg).
Time frame
3 months post-procedureSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: