The ULTRA-EVOLUT Randomized Control Trial: A Head-to-Head Comparison of Latest-Generation Transcatheter Aortic Valves
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Device Success Rate at 30 Days
研究概览
简要总结
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
详细描述
Study Design Overview
This is a prospective, randomized, controlled, single-blind, two-arm parallel-group trial conducted at a single tertiary cardiac care center. The study aims to compare the latest-generation balloon-expandable transcatheter heart valve (SAPIEN 3 Ultra Resilia) versus the latest-generation self-expanding transcatheter heart valve (Evolut FX) in patients with severe symptomatic aortic stenosis who are deemed appropriate for transcatheter aortic valve implantation (TAVI) by the local heart team.
Scientific Rationale
Previous landmark trials (e.g., PARTNER 3 and Evolut Low Risk) have established the safety and efficacy of TAVI in intermediate- to low-risk patients. However, direct head-to-head comparisons between the newest commercially available valve iterations-the SAPIEN 3 Ultra Resilia (featuring anti-calcification tissue treatment) and the Evolut FX (offering enhanced radial strength and conformability)-are lacking. Observational and registry data suggest potential differences in paravalvular leak rates, hemodynamic performance, and permanent pacemaker implantation rates, but randomized evidence is needed to eliminate bias and guide evidence-based, patient-specific valve selection.
Study Population and Enrollment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
SAPIEN 3 Ultra Resilia
Balloon-expandable transcatheter aortic valve with anti-calcification tissue treatment.
干预措施: SAPIEN 3 Ultra Resilia (Device)
Evolut FX
Self-expanding transcatheter aortic valve with enhanced radial strength and conformability.
干预措施: Evolut FX (Device)
结局指标
主要结局
Device Success Rate at 30 Days
时间窗: 30 days post-procedure
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)
次要结局
- Mean Aortic Valve Gradient(3 months post-procedure)
研究者
Ahmed Abdel Rahim Hassaan
Assistant Lecturer
Assiut University