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)

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Kardi Ai medical device, an ECG telemetry monitoring system, in adults with confirmed or suspected heart rhythm disorders. The study aims to determine how well the device detects various heart rhythm problems by comparing its results to those of experienced cardiologists. Key questions include the device's sensitivity and specificity for all monitored heart rhythm disorders combined and individually, as well as the quality of the ECG recordings. Participants will receive the Kardi Ai device, which includes hardware components like the Polar H10 chest strap and a mobile app. They will use the device independently at home to record ECG data on at least five different days, with a total recording time of at least 10 hours. If bradycardia is suspected, one overnight recording of at least six hours is required. The collected data will be transmitted to the Kardi Ai cloud for AI analysis of seven specific heart rhythm disorders. During the study, participants will install and use the mobile app, complete scheduled ECG recordings, and transmit data for analysis. Physicians will annotate individual ECG recordings, and statisticians will compare AI results with physician assessments. After data collection, participants will complete a satisfaction questionnaire about the Kardi Ai system. The primary outcome measures focus on evaluating the device's sensitivity and specificity across all heart rhythm disorders during the approximately three-week measurement period.

Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System