Long-term Results of Percutaneous Left Atrial Closure at Brest University Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Effectiveness of left atrial appendage occlusion with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories
研究概览
简要总结
Atrial Fibrillation represents an important risk of cardioembolic stroke. In more than 90% of cases, thrombus originate in the left atrial appendage. Therefore guidelines recommend the anticoagulation of patients with atrial fibrillation and a significant cardioembolic risk, predicted by the CHA2DS2VASc score.
However, serious bleeding complications may definitively contraindicate the use of anticoagulants.
For those patients, percutaneous Left Atrial Appendage Occlusion (LAAO) has became a recommended alternative to prevent the thrombus formation and reduce the risk of cardioembolic events.
In the CHU of Brest, more than 120 patients have been treated with LAAO for the last 8 years with two different occluder devices : WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories.
This retrospective longitudinal observational study named CLAPOT (CHU of Brest' Left Atrial Appendage Percutaneous Occlusion Treatment) aims to evaluate the long term results of this procedure for effectiveness and safety and to compare the results between the two devices (Watchman and Amplatzer).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Non opposition
- •All patients with non-valvular atrial fibrillation and a definitive contraindication to anticoagulants who underwent left atrial appendage occlusion in the CHU of Brest between December 2014 and August 2023
排除标准
- •Patients under tutorship or curatorship
- •Formulated opposition
结局指标
主要结局
Effectiveness of left atrial appendage occlusion with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratories
时间窗: From 15 February 2024 to 15 April 2024
Effectiveness is assessed by a composit endpoint that combines transient ischemic attack (TIA)/stroke, systemic embolism, cardiovascular mortality or All-cause mortality
次要结局
- Safety of left atrial appendage occlusion (LAAO) with both devices WATCHMAN®, Boston Scientifc and AMPLATZER Amulet®, Abbott Laboratoriesleft atrial.(At 8 weeks)