Medtronic CoreValve™ Evolut™ PRO System China Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- All-cause Mortality
研究概览
简要总结
Interventional study to evaluate the safety and efficacy of the Medtronic CoreValve™ Evolut™ PRO System when used by China implanting centers in Chinese patients with severe symptomatic aortic stenosis (AS) who are at high risk for Surgical Aortic Valve Replacement (SAVR).
详细描述
The study is targeting 6 centers with a maximum of 8 centers in China and estimating 65 subjects with a maximum of up to 70 subjects with attempted implants including 50 subjects with an attempted implant in primary study population and the first two attempted subjects at each site for roll-in population. The subjects will follow the assessment with pre and post-procedure, discharge, 30 days(primary endpoint), 6 months, 1 year, and annually through 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortic valve area (AVA) < 1.0 cm2 (or indexed AVA <0.6 cm2/m2) OR mean gradient > 40 mmHg, OR max aortic velocity > 4.0 m/sec
- •High risk for SAVR defined as STS-PROM score ≥ 8% AND ≤ 15%, OR documented Heart Team agreement of high risk for AVR due to frailty or comorbidities
- •Symptoms of aortic stenosis and NYHA ≥ II
排除标准
- •Age is less than 65 years old
- •Non-calcified aortic valve
- •Bicuspid aortic valve with no raphe or 2 raphes (Sievers classification type 0 or type 2)
- •Ascending aortic diameter > 4.5 cm
结局指标
主要结局
All-cause Mortality
时间窗: 30 days
All-cause mortality at 30 days
Percentage (%) of Subjects With Evaluable Echocardiograms With Moderate or Severe Aortic Regurgitation by Transthoracic Echocardiography (TTE)
时间窗: 30 days
Percentage (%) of Subjects with evaluable echocardiograms with moderate or severe aortic regurgitation by transthoracic echocardiography (TTE)
次要结局
- Incidence of an VARC II Combined Composite(30 days)
- Event Rates of the Individual Components of the VARC II Composite(30 days)
- New Permanent Pacemaker Rate(30 days)
- Device Success Rate(Between 24 hours and 7 days post procedure)
- Valve Performance Parameter - Mean Aortic Gradient(30 days)
- Valve Performance Parameter - Effective Orifice Area(30 days)
- Valve Performance Parameter -Degree of Aortic Regurgitation (Transvalvular, Paravalvular, Total)(30 days)