Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PulseOn Oy
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing sufficient patient convenience for using the device for the intended duration of two weeks
研究概览
简要总结
The study investigates the performance pf PulseOn Arrhythmia Monitor System that includes a wrist-worn device, which combines continuous optical heartbeat interval monitoring and intermittent ECG measurement, and a data management system used by healthcare professionals for data observation, in the detection of previously undiagnosed cardiac arrhythmias, especially atrial fibrillation.
详细描述
The study consists of monitoring voluntary subjects with PulseOn Arrhythmia Monitoring System for the period of two weeks. The subjects are recruited mainly through newspaper advertisements. The study is executed in Tampere and Helsinki areas, Finland.
During the two week monitoring time, the subjects are instructed to wear the wrist device continuously, except when taking the device off e.g. for going to sauna or swimming, and for charging. The subjects are instructed to perform a 35-second ECG measurement (recording) in three cases:
- Scheduled recording four times a day
- In case of suspecting arrhythmic event, i.e. feeling symptoms
- In case the wrist device instructs to perform a recording by vibrating and showing an LED light
The data collected in the study is analysed post-hoc. In the post-hoc analysis, the cardiac rhythm assessed automatically from the ECG measurements is visually confirmed by a cardiologist.
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
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing sufficient patient convenience for using the device for the intended duration of two weeks
时间窗: Duration of patient measurement, i.e. two weeks
The feedback from the subjects should show at least grade 3 in a scale of 1-5 for the "comfortability of using the wrist device".
Diagnostic performance improvement with continuous optical measurement
时间窗: Duration of patient measurement, i.e. two weeks
Percentual improvement in the performance of detecting previously undiagnosed atrial fibrillation in the study population by the continuous PPG-based heartbeat interval monitoring when compared with relying only on scheduled and symptom -based ECG measurements. Cardiac rhythm assessed by a cardiologist from the ECG measurements that are made as a result of PPG-based arrhythmia notifications is compared with rhythm assessments made only from the scheduled and symptom-based ECG measurements. It is evaluated whether more subjects can be diagnosed having atrial fibrillation with the help of continuous PPG-based rhythm monitoring.
Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing the adequacy of the obtained ECG data for clinical decision making.
时间窗: Duration of patient measurement, i.e. two weeks
Data recorded by the study subjects during the two-week study time is assessed by a cardiologist and subjects are classified as having: "no observed arrhythmias", "atrial fibrillation episode(s)", "other potential arrhythmia", or "unconfident assessment" (due to the quality or lack of data). The percentage of "unconfident assessment" shall be less than 20% of the subjects.
次要结局
- Showing the benefit of the combined wrist-worn PPG and ECG solution in detecting other cardiac arrhythmias than atrial fibrillation.(Duration of patient measurement, i.e. two weeks)
- Evaluation of the necessity of performing scheduled ECG measurements in addition to ECG measurements triggered by PPG-based arrhythmia notifications for detecting atrial fibrillation.(Duration of patient measurement, i.e. two weeks)
- Quality of the measured ECG signals(Duration of patient measurement, i.e. two weeks)
- Assessment of the subjects' adherence in using the solution.(Duration of patient measurement, i.e. two weeks)
- Feedback about the usability of the evaluated solution from study personnel.(At the end of the study i.e. the end of 2022.)
- Feedback about the usability of the evaluated solution from study subjects.(At the end of the 2-week measurement period)
- Benefit of optical measurement for the speed of detecting atrial fibrillation(Duration of patient measurement, i.e. two weeks)
- Evaluation of the accuracy of automatic ECG analysis algorithms when comparing with manual annotations by a cardiologist.(Duration of patient measurement, i.e. two weeks)