Experience With Percutaneous Transcatheter Aortic Valve Implantation in Patients With Symptomatic Aortic Valve Disease in Two German Centers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,370
- 试验地点
- 2
- 主要终点
- incidence of post-TAVI aortic regurgitation
研究概览
简要总结
The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.
详细描述
The TAVI program in our center started on November 2007. As part of the national policy for quality assurance in medicine a detailed clinical characterization of the TAVI-population was required. Furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. In our center we designed and are routinely using a TAVI database which fulfills the authority requirements as well as has additional data needed for planning and documentation of TAVI procedure. Since there is already a considerable number of TAVI patients in this database we aim to perform statistical analyses answering different question in this filed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aortic stenosis
- •Intermediate-to-high risk for surgery
- •Heart team decision
排除标准
- •Contraindication to transfemoral TAVI procedure
结局指标
主要结局
incidence of post-TAVI aortic regurgitation
时间窗: 30 days
echocardiographicall and angiographycally determined
次要结局
- incidence of bleeding complications(30 days)
- mortality(30 days)
- mortality rate(5-years)
- incidence of cerebrovascular events(5-years)
- incidence of new pacemaker implantation(1-year)
研究者
Prof. Dr. Julinda Mehilli
Prof. MD
LMU Klinikum