NCT00719277Unknown不适用
Pilot Clinical Study of the Sleuth Implantable ECG Monitoring System
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Diagnostically viable ECG signals
研究概览
简要总结
The purpose of the study is to evaluate the safety and performance of the Sleuth Monitoring system.
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
- Diagnostic
- 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
- •Age > = 18 years at time of enrollment
- •Either of the following:
- •MI > 30 days prior to enrolment and LVEF < = 35% by echocardiography (or nuclear imaging as necessary)
- •Syncope of unknown etiology
排除标准
- •Life expectancy < 12 months following enrollment
- •Active infection
结局指标
主要结局
Diagnostically viable ECG signals
时间窗: daily
次要结局
- rate of device-related adverse events(1, 6, and 12 months)
研究者
研究点 (2)
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