A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- CardicacSense1 atrial fibrillation detection rate
研究概览
简要总结
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation.
The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf cleared Holter ECG device
详细描述
The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib). Study design as as follows:
100 subjects, 50 (at least 30% of each gender) with A-fib and 50 without (at least 30% of each gender).
All subjects will be measured during at least 24 hours. Primary endpoint - A-Fib detection Control: Holter device will be the reference
For PPG analysis, each one hour will be considered as an event:
If A-Fib is present for more than accumulated 5 minutes in that specific hour then it shall be considered an "A-Fib hour" If A-fib was present for less than accumulated 5 minutes then it shall be considered a "Non-A-Fib hour".
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of eighteen (18) year and above
- •Diagnosed with atrial fibrilation (Permanent of persistent), or healthy participants able to and willing to sign the informed consent form For control group-no known cardiac problems
排除标准
- •Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study.
- •Subjects with low perfusion as indicated by the watch
- •Women who are pregnant or breastfeeding
结局指标
主要结局
CardicacSense1 atrial fibrillation detection rate
时间窗: 24 to 48 hours
Comparison of the number of atrial fibrillation sessions detected by reference comparing to PPG and ECG sensors in CardiacSense device.
Safety of CardicacSense1
时间窗: 24 to 48 hours
Incidence and severity of device related Adverse Events
次要结局
- Usability(24 to 48 hours)