A Prospective, Single-Center, Controlled Study to Evaluate the Performance of CardiacSense PPG Sensor in the CardiacSense1 Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- PPG and Holter ECG signals correlation
研究概览
简要总结
study to evaluate the performance of the CardiacSense1's embedded PPG under different environmental and physical conditions
详细描述
The clinical study is a Prospective, Open, Single-Center, and Controlled Study to Evaluate the Performance of a PPG sensor in the CardiacSense1 device.
The CardiacSense1 is a wrist worn device designed to detect atrial fibrillation (AF). The AF detection of the device is based on a portable photoplethysmograph (PPG) sensor that is designed for continuous heart rate monitoring. The photoplethysmograph is a noninvasive circulatory signal related to the pulsatile volume of blood in the tissue.
Twenty (20) subjects (female and male) that do not suffer from atrial defibrillation and additional four (4) patients who are diagnosed as suffering from atrial fibrillation will be enrolled to the study.
Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded activity of an FDA-cleared ECG Holter, on a beat-by-beat basis will be performed on the following conditions:
All subjects will be exposed to 45 minutes of indoor standard office fluorescent light and 45 minutes to outdoor sunlight during mid-day. In addition, Subjects will be asked to walk for 1 minute once every 10 minutes and will be exposed to an indoor environment of 22±3 - 28±3 degree Celsius for 45 minutes and outdoor temperature of at least 15 degree Celsius, on the other 45 minutes.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of eighteen to eighty-five (18-85) years
- •Ability and willing to sign informed consent form
- •For subjects in groups other than Heart Arrhythmias- Self-declared not to be diagnosed with any arrhythmia
- •Compliance with hair, age, BMI skin and heart arrhythmia variables as defined above
排除标准
- •Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.
- •Subject with low perfusion indicated by the watch
- •Pregnant or breastfeeding woman (women of child-bearing potential must have a negative pregnancy test within screening period).
结局指标
主要结局
PPG and Holter ECG signals correlation
时间窗: 90 Minutes
Evaluation of the correlation between PPG signals and Holter ECG signals with respect to R-R signal intervals.
PPG individual peak detection
时间窗: 90 Minutes
Comparison of CardiacSense1 PPG individual peak detection to the corresponding recorded activity of an FDA-cleared ECG Holter, on a beat-by-beat basis.
次要结局
- signal intensity under different conditions(90 minutes)
- Adverse events(90 minutes)