Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Stroke
研究概览
简要总结
The aim of this collaborative analysis is to evaluate stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. In the absence of large randomized controlled trials, we will conduct a large collaborative patient-pooled meta-analysis on 30-day stroke and mortality in patients undergoing primary transfemoral TAVI with either MCV or ES valve.
详细描述
The main aim of this patient-pooled analyses is to compare stroke rates and mortality in patients undergoing TAVI with the self-expandable MCV prosthesis compared to the balloon-expandable ES valve. However, this collaboration may also be used to compare various outcomes.
Studies were included if they complied with the following requirements: original prospective studies, including patients with aortic valve stenosis treated with transfemoral TAVI of native valves and reporting of 30 day stroke outcomes according to VARC criteria or other specified corresponding criteria . Moreover, to be included studies had to report both the use of self-expandable MCV prosthesis and the balloon-expandable ES valve in more than 50 patients in each arm to ensure experience in use of the valves. Studies were excluded if they only addressed patients undergoing valve-in-valve and re-do procedures or bicuspid valves or included the same study population. Principal Investigators of these studies were approached for collaboration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing transfemoral transcatheter aortic valve procedures
排除标准
- •valve-in-valve procedures, other acces routes than transfemoral
结局指标
主要结局
Stroke
时间窗: 30 days
Stroke during the first month after TAVI
Mortality
时间窗: 30 days
Death during the first month after TAVI
次要结局
- New onset atrial fibrillation(30 days)
- Pacemaker implantation(30 days)
- Myocardial infarction(30 days)
- Bleeding(30 days)
研究者
Jan J. Piek, MD, PhD
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)