Comparison of Safety and Efficacy of Left Atrial Appendage Occlusion Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Effect of LAA occlusion by LARIAT device
研究概览
简要总结
Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In the last two decades the number of hospitalizations for AF has increased two- to three-fold. More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke compared with those without AF.
This registry will collection information on two devices that are used to treat AF. The WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices on outcomes related to AF has not been studied. This study will look to compare the two devices to see how the outcomes may vary.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients who have had a LARIAT LAA device occlusion
排除标准
- •Patients who have PFO/ASD/critical carotid artery (>70% blockage) disease and hemorrhagic strokes
结局指标
主要结局
Effect of LAA occlusion by LARIAT device
时间窗: Change from Day 0 to 356 post-procedure
This registry will provide data on patient outcomes at different times during follow up.This includes: changes in the appendage size, shape and patients medical history.
次要结局
- Compare effectiveness of LAA occlusion procedure by evaluating LAA jet velocities(Days 0, 90, 180, 365 post-procedure and annually thereafter)