Russian National Registry of LAAO
Russian National Registry of Left Atrial Appendage Occlusion
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.
研究概览
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- age ≥18 years nonvalvular atrial fibrillation,
- CHA2DS2VASc ≥2,
- high risk of hemorrhagic events,
- non-compliance with pharmacological anticoagulant therapy
Exclusion Criteria:
- significant mitral valve disease,
- left ventricular ejection fraction <35%,
- the tendency to systemic thrombosis,
- severe co-morbidities
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)
大体时间：12 months
|
12 months
|
|
|
The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death
大体时间：12 months
|
Primary efficacy endpoint
|
12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Procedure success rate
大体时间：intraprocedural
|
successful left atrial appendage occluder implantation rate
|
intraprocedural
|
|
Peridevice leakage
大体时间：6 months
|
incidence rates of significant (≥5mm) leakage
|
6 months
|
合作者和调查者
调查人员
- 首席研究员：Karapet Davtyan, PhD、National Research Center for Preventive Medicine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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