Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System Using Artificial Intelligence to Evaluate ECGs Measured by Hardware Component (POLAR H10 Chest Strap)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 115
- 试验地点
- 4
- 主要终点
- Evaluation of sensitivity and specificity of Kardi Ai across all measurements and heart rythm disorders.
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of medical device Kardi Ai, an ECG telemetry monitoring device in adult population.
The main questions it aims to answer are:
- What is the sensitivity and specificity of Kardi Ai device for all monitored heart rythm disorders (combined)
- What is the sensitivity and specificity of Kardi Ai device for each of the monitored heart rythm disorders
- What is the quality of the ECG recordings
Participants will receive Kardi Ai medical device. They will use it to collect ECG recordings from at least 5 different days and in total collect records of at least 10 hours duration.
详细描述
The primary objective of the study is to correctly find the given heart rythm disorders using Kardi Ai across all measurements compared to an experienced cardiologist.
The primary objective will be evaluated across all heart rhythm disorders together, using the statistics used in the evaluation of diagnostic tests (sensitivity, specificity, if applicable, positive predictive values and negative predictive values predictive values of the test).
Study procedure:
- Familiarisation of the subject with the clinical trial
- Signing the informed consent
- Handover of the Kardi Ai medical device (packaging hardware components of the Polar H10 chest strap, including instructions for use and QR codes for installation of the Kardi Ai app), registration of the subject in the physician's electronic Case Report Form.
- Installation and commissioning of the mobile pohone application by the subject.
- Independent measurement of the subject in the home environment. Measurements should be done at least 3 times per week for the duration of at least two hours each.
As part of the ECG recording for the purpose of the clinical trial, measurements will be taken on at least five different days; and the total recording time must be at least 10 hours. If bradycardia is suspected, at least one measurement must be taken overnight for at least 6 hours. 6. Raw data for each measurement in the Kardi Ai mobile app will be transmitted to the Kardi Ai cloud, where it will be analyzed by AI, including evaluation of the following 7 heart rhythm disorders:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 above 18 years
- •Signed informed consent/willingness to cooperate
- •Confirmed or suspected heart rhythm disorder of a cardiac rhythm disorder
- •Ability to use a smartphone and mobile app Kardi Ai
- •The subject's mobile phone meets the minimum requirements for the Kardi Ai app to work
排除标准
- •Confirmed pregnancy
- •Allergic reactions to standard substances used in manufacture of clothing or other textiles
- •Superficial wound or skin irritation at the site of the chest belt attachment
结局指标
主要结局
Evaluation of sensitivity and specificity of Kardi Ai across all measurements and heart rythm disorders.
时间窗: From enrollment to the end of measurements at 3 weeks
Evaluation of sensitivity and specificity of Kardi Ai across all measurements and heart rythm disorders.
次要结局
- Evaluation of sensitivity and specificity of Kardi Ai across all measurements for each monitored heart rythm disorders.(From enrollment to the end of measurements at 3 weeks)