Registry of Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 20
- 主要终点
- Composite of all-cause mortality, stroke and bleeding
研究概览
简要总结
Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention. The aim of the study is to assess the procedural safety on stroke and bleeding prevention of LAAC in patients with non-valvular atrial fibrillation (NVAF) and ESCKD on HD.
详细描述
Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Age> 18 years.
- •Stage V chronic kidney disease (GFR <15 ml / min) in hemodialysis at the time of left atrial appendage closure.
- •History of atrial or valvular fibrillation (paroxysmal, persistent, permanent).
- •Less moderate embolic risk (CHA2DS2-VASc ≥2) or active oral anticoagulant therapy due to atrial fibrillation.
- •High associated hemorrhagic risk (HASBLED ≥ 3) or a history of major bleeding (BARC> 2).
- •The patient has been informed of the characteristics of the study and has provided written informed consent.
排除标准
- •Life expectancy < 2 years.
- •Indication for OA different from NVAF.
- •Severe pericardial effusion.
- •Previous percutaneous closure of atrial septal defect.
- •Intracardiac thrombus.
- •Severe hepatic dysfunction with spontaneous INR (International Normalized Ratio) > 1.
- •The patient refuses to participate in the study.
结局指标
主要结局
Composite of all-cause mortality, stroke and bleeding
时间窗: 24 month
Composite: Stroke or Transient Ischemic Attack (TIA), Systemic embolism, Major bleeding event (BARC ≥ 2). Systemic embolism, Major bleeding event (BARC ≥ 2)
次要结局
- Periprocedural major adverse events(2 days)
- Echocardiographic adverse events during follow up(24 month)