French Database of Left Atrial Appendage Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France
研究概览
简要总结
Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. However, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy.
This national database record per-procedure and follow-up data of patients treated by left atrial appendage closure.
This database is strictly observational.
Percutaneous left atrial appendage closure is performed only for the purpose of patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to a french interventional cardiology department for percutaneous left atrial appendage closure in routine care
- •Signature of an inform consent form for inclusion of data recorded during care in the database
排除标准
- 未提供
结局指标
主要结局
Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France
时间窗: 1 year
次要结局
- Unexplained Death rate after left atrial appendage closure(1 year)
- Cost of patient follow-up after left atrial appendage closure(1 year)
- Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures)(1 year)
- Death rate from cardiovascular disease after left atrial appendage closure(1 year)
- Adverse events related to the procedure(1 year)
- Cost of the procedure of left atrial appendage closure(Costs will be assessed for the duration of hospital stay, an expected average of 3 days)
- Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs)(1 year)
研究者
Philippe Le Corvoisier
MD
Henri Mondor University Hospital