NCT03826225已完成不适用
Cardiac Monitor Employee Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate WCM System End-To-End Performance
研究概览
简要总结
This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to evaluate end-to-end performance of a cardiac monitor system and associated data management accessories.
详细描述
The objective of this study is to evaluate the usability of the Wearable Cardiac Monitor (WCM) system including the WCM, Mobile Monitors (patient and clinician), Magnet and LATITUDE Clarity(TM) Server. The study will exercise the end-to-end system utilizing human ECG data generated by the wearable cardiac monitor.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and capable to provide informed consent
- •Age 18 or above
- •Employee of the study sponsor
- •Willing and able to follow protocol requirements
排除标准
- •Currently enrolled in another clinical study that interferes with data collection
- •Currently implanted with an active medical electronic device
- •Known allergies to the materials that may come in contact with the skin
- •Any active skin condition on the chest reported by the subject
结局指标
主要结局
Evaluate WCM System End-To-End Performance
时间窗: 3 months
Characterize rate of success of wireless data transmissions from wearable cardiac monitor to LATITUDE Clarity(TM) server
次要结局
未报告次要终点
研究者
研究点 (1)
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