NCT00841529终止2 期
Evaluation of the Cardioblate Closure Device in Facilitating Occlusion of the Left Atrial Appendage
Medtronic Cardiovascular10 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Complete occlusion of the left atrial appendage
研究概览
简要总结
The purpose of this study is to evaluate the performance of the Cardioblate Closure Device to occlude the LAA
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is greater than or equal to 18 years of age and less than or equal to 80 years of age
- •Concomitant indication for cardiac surgery for one or more of the following:mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, CABG (>=60 years of age), CABG (< 60 years of age with a history of atrial fibrillation), surgical ablation or Maze procedure
- •The subject is willing and able to provide written informed consent and comply with study requirements
- •The subject is not contra-indicated for intra-operative transesophageal echocardiogram (TEE)
排除标准
- •Thrombus in the LAA and/or left atrium
- •Prior LAA isolation attempts
- •Subject is unable to take an anticoagulant during the study follow-up period
- •Subject is undergoing an emergency cardiac procedure
- •Life expectancy of less than 12 months
- •Pregnancy or desire to be pregnant within the 12 months of the study procedure
结局指标
主要结局
Complete occlusion of the left atrial appendage
时间窗: 3 Months
次要结局
- To evaluate the composite incidence rate of device-related adverse events(Discharge/30 days)
研究者
研究点 (10)
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