A Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT (The CHOICE Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- 'Device success' as recently defined by the Valve Academic Research Consortium
研究概览
简要总结
A randomized controlled multicenter study comparing the acute hemodynamic performance of the Edwards Sapien XT and the Medtronic CoreValve transcatheter heart valves in high risk patients with severe symptomatic aortic stenosis.
详细描述
Study design: randomized open-label multicenter
Primary endpoint:
'Device success' as recently defined by VARC which is a 'technical' composite endpoint including:
- Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system,
- Correct position of the device in the proper anatomical location,
- Intended performance of the prosthetic heart valve (aortic valve area > 1.2 cm2 and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, without moderate or severe prosthetic valve AR) and
- Only one valve implanted in the proper anatomical location.
Secondary endpoints:
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe aortic valve stenosis defined as aortic valve area (AVA) ≤ 1cm2 or 0.6 cm2/m2
- •Presence of clinical symptoms defined as New York Heart Association (NYHA) functional class ≥ 2
- •Age > 75 years and/or Logistic EuroSCORE ≥ 20% and/or STS risk score ≥ 10% and/or contraindication to conventional surgical aortic valve replacement (porcelain aorta, previous chest radiation, chest deformation)
- •Native aortic valve annulus measuring 20-25 mm
- •Patients must be suitable for a transfemoral vascular access
- •The patient signing a written informed consent prior to intervention
排除标准
- •Life expectancy < 12 months due to co-morbid conditions
- •Native aortic valve annulus < 20 mm and > 25 mm (this could be amended if further valve sizes for the transfemoral approach become available for both prostheses during the study period)
- •Pre-existing aortic bioprosthesis
- •Cardiogenic shock or hemodynamic instability
- •History of, or active endocarditis
- •Contraindications for a transfemoral access
- •Active peptic ulcer or upper gastro-intestinal bleeding within the prior 3 months.
- •Hypersensitivity or contraindication to aspirin, heparin or clopidogrel
- •Active infection requiring antibiotic treatment
- •An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 3 months post-enrolment
- •Patients actively participating in another drug or device investigational study and have not yet completed the primary endpoint follow-up period
研究组 & 干预措施
TAVI with Edwards Sapien XT valve
干预措施: Transcatheter Aortic Valve Implantation (TAVI) (Procedure)
TAVI with Medtronic CoreValve
干预措施: Transcatheter Aortic Valve Implantation (TAVI) (Procedure)
结局指标
主要结局
'Device success' as recently defined by the Valve Academic Research Consortium
时间窗: Immediately after the procedure
Device success is a 'technical' composite endpoint including successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system, correct position of the device in the proper anatomical location, intended performance of the prosthetic heart valve (aortic valve area \> 1.2 cm2 and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/s, without moderate or severe prosthetic valve AR) and only one valve implanted in the proper anatomical location.
次要结局
- VARC-defined combined safety endpoint(30 days)
- VARC-defined combined efficacy endpoint(1 year)