The JenaValve" EvalUation of Long Term Performance and Safety In PaTients With SEvere Aortic Stenosis oR Aortic Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 15
- 主要终点
- All-cause mortality
研究概览
简要总结
The purpose of this registry is to observe longterm performance and safety of the JenaValve TAVI system, in routine medical and everyday conditions.
详细描述
The objective of this study is to evaluate the long term safety and effectiveness of the CE-marked JenaValve System Transapical in an elderly patient population with severe aortic stenosis and/or aortic insufficiency who are at high risk for open surgical aortic valve replacement.
The target study population will consist of elderly patients suffering from severe symptomatic degenerative aortic valve stenosis and/or aortic insufficiency who show an increased risk for an open aortic valve replacement surgery due to existing co-morbidities.
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 suitable for TAVI with the JenaValve according to instructions for use
排除标准
- •Patients unsuitable for TAVI with the JenaValve according to instructions for use
结局指标
主要结局
All-cause mortality
时间窗: 30 day
30-day mortality of procedure is defined as all deaths within 30 days after implantation of the JenaValve prosthesis irrespective of the underlying cause of death.
次要结局
- Device Success(Index Procedure and Immediate Post-operative)
- SF-12 Survey of Quality of Life(at 12 months)
- Device Effectiveness(Prior to discharge, at 3, 6, 12, 24 and 36 months)
- Safety Endpoints(peri- and post-operatively and at 3, 6, 12, 24 and 36 months)
- Combined Safety Endpoint(at 30 days)
- Combined Efficacy Endpoint(at 12 months)