Russian National Registry of Left Atrial Appendage Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)
研究概览
简要总结
The first Russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (LAAO) using the Watchman device and the Amplatzer cardiac plug. This government-funded catheter-based LAAO program was started in September 2015 and was completed in December 2017. Data collection was finished in December 2018. Five clinics agreed to participate in the study.
Patients' baseline characteristics, procedure, and follow up data were collected according to established registry protocol. Patients were followed at 45 days, 3, 6 and 12 months after enrollment. At each follow-up visit, the data regarding clinical events and healthcare utilization was collected.
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
- •age ≥18 years nonvalvular atrial fibrillation,
- •CHA2DS2VASc ≥2,
- •high risk of hemorrhagic events,
- •non-compliance with pharmacological anticoagulant therapy
排除标准
- •significant mitral valve disease,
- •left ventricular ejection fraction <35%,
- •the tendency to systemic thrombosis,
- •severe co-morbidities
结局指标
主要结局
Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)
时间窗: 12 months
The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death
时间窗: 12 months
Primary efficacy endpoint
次要结局
- Peridevice leakage(6 months)
- Procedure success rate(intraprocedural)