First in Man Study of the JenaValve TAVI Plus System Transfemoral
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- All-Cause Mortality
研究概览
简要总结
The objective of this study is to evaluate feasibility, safety and effectiveness of the first generation transfemoral JenaValve Pericardial TAVR System (formerly named JenaValve TAVI Plus System- Transfemoral) in an elderly patient population with severe aortic stenosis who are at high risk for surgical aortic valve replacement.
详细描述
The study is designed as a prospective, multi-center trial conducted at 2 centers in Germany enrolling up to 12 subjects. Each patient will be followed for 2 years. The last patient's follow-up will end in February 2016. It is planned that the study will end in June 2016. Study endpoints are defined in accordance with the "Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium (VARC-2)". These endpoint definitions combine the expertise of surgeons, interventionalists, medical cardiologists, clinical trial and other specialists and allow for comparison of different trials concerning effectiveness and safety in TAVI.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with severe native aortic valve stenosis
- •NYHA functional class II or higher
- •Increased risk for surgical aortic valve replacement
- •Comply with post-operative follow-up visits and requirements
排除标准
- •Combined aortic valve disease with severe aortic insufficiency
- •Presence of moderate mitral insufficiency or previous mitral prosthesis
- •Severe pulmonary hypertension
- •Congenital uni- or bicuspid aortic valve
- •Endocarditis or active infection
- •Life expectancy < 12 months
- •Need for emergency surgery for any reason
结局指标
主要结局
All-Cause Mortality
时间窗: 30 days
30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve Plus Prosthesis irrespective of the underlying cause of death.
次要结局
- Incidence rate and standard deviation of VARC-2 Individual Safety Endpoints(Index Procedure and Immediate Post-operative)