RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 836
- 试验地点
- 10
- 主要终点
- Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up
研究概览
简要总结
Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.
详细描述
The purpose of the DOUBEL-CHOICE study is to demonstrate non-inferiority of a latest-generation self-expanding valve (SEV) (ACURATE neo2, Boston Scientific, Marlborough, MA, USA) in comparison to another latest-generation SEV (Evolut Pro, Pro+ and FX, Medtronic Inc., Minneapolis, MN, USA) and of a minimalist approach vs. standard of care with respect to safety and efficacy in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blinding of cardiologists, anesthesiologists and patients is not possible due to the type of interventions.
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 symptomatic aortic valve stenosis (AVA ≤1 cm² or 0.6 cm²/m²) with indication for transcatheter aortic valve implantation according to heart team consensus
- •Perimeter-derived native aortic valve annulus diameter measuring 21-27 mm
- •Heart team consensus that the patient is anatomically suitable for both device types
- •Suitability for transfemoral vascular access
- •Written informed consent
排除标准
- •Life expectancy <12 months due to comorbidities
- •Native aortic valve annulus <21 mm and >27 mm
- •Bicuspid aortic valve
- •Cardiogenic shock or hemodynamic instability
- •Active endocarditis
- •Contraindications for transfemoral access
- •Active peptic ulcer or upper gastro-intestinal bleeding <2 weeks
- •Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
- •Contraindication for a specific treatment strategy (minimalist approach vs. standard of care) as judged by the Heart Team
- •Clear patient-specific clinical or anatomic reasons to prefer one treatment strategy or valve type over the other
- •Active infection requiring antibiotic treatment
- •Age <18 years
- •Participation in another interventional trial where the primary endpoint has not been reached
研究组 & 干预措施
Group 1
Patients treated with the ACURATE neo2 valve using a minimalist approach
干预措施: ACURATE neo2 (Device)
Group 1
Patients treated with the ACURATE neo2 valve using a minimalist approach
干预措施: minimalist approach (Procedure)
Group 2
Patients treated with the ACURATE neo2 valve under standard of care
干预措施: ACURATE neo2 (Device)
Group 2
Patients treated with the ACURATE neo2 valve under standard of care
干预措施: Standard of care (Procedure)
Group 3
Patients treated with the Evolut Pro, Pro+ or FX valve using a minimalist approach
干预措施: minimalist approach (Procedure)
Group 3
Patients treated with the Evolut Pro, Pro+ or FX valve using a minimalist approach
干预措施: CoreValve Evolut Pro, Pro+ and FX (Device)
Group 4
Patients treated with the Evolut Pro, Pro+ or FX valve under standard of care
干预措施: CoreValve Evolut Pro, Pro+ and FX (Device)
Group 4
Patients treated with the Evolut Pro, Pro+ or FX valve under standard of care
干预措施: Standard of care (Procedure)
结局指标
主要结局
Devices: Composite of all-cause mortality, stroke, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation at 30-day follow-up
时间窗: Day 30
Strategy: composite of all-cause mortality vascular complications (major + minor according to VARC-3), bleeding complications (type 1-4 according to VARC-3), infections requiring antibiotic treatment, and neurologic events (NeuroARC type 1-3)
时间窗: Day 30
次要结局
未报告次要终点