NCT00567515已完成2 期
Safety and Effectiveness of Left Atrial Appendage Occlusion
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Safety - Device related complications
研究概览
简要总结
This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant Maze/Ablation procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Documented history (paroxysmal, persistent or permanent) of AF [one episode within the last 12 months of enrollment]
- •Elective Maze procedure
- •Suitable anatomy
- •Able and willing to sign informed consent
- •Age over 18 years
排除标准
- •Patient from Intensive Care Unit with either:
- •intra-venous catecholamines
- •cardiac index <1.8 l/min.
- •Reoperative Cardiac Surgery
- •Systemic or Inflammatory disease
- •Recent myocardial infarction (< 21 days)
- •History of pericarditis
- •Patient taking part in any other device or drug study
- •Patient with known sensitivity or allergy to any of the device components
结局指标
主要结局
Safety - Device related complications
时间窗: 30 days
Efficacy - Occlusion of the LAA
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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