Clinical Trial
The clinical evaluation focused on the safety and effectiveness of the Kardi Ai medical device, an ECG telemetric monitoring system that uses artificial intelligence to analyze ECG data measured with a hardware component — the POLAR H10 chest strap.
The study was designed as a prospective, multicenter, national, interventional study.
Participating centers:
University Hospital Ostrava – Internal Medicine and Cardiology Clinic
University Hospital Olomouc – 1st Department of Internal Medicine – Cardiology
Number of evaluated subjects: 113
Results of the clinical trial
The clinical trial of the Kardi Ai medical device demonstrated that users can independently record long-term, high-quality ECG data without limitations in movement (>90% excellent ECG quality), suitable for further analysis by physicians as well as automated AI evaluation.
The device is highly user-friendly (97.3% satisfaction).
The overall positive predictive value (PPV) of AI-based arrhythmia detection was 82.4%.
The overall negative predictive value (NPV) for confirming the absence of arrhythmia was 94.6%.
The overall AI accuracy (the proportion of correctly classified healthy and affected subjects) reached 93.3%.
The high overall accuracy (corresponding to a specificity of 97.8%) indicates a very low likelihood of false positives, which could otherwise lead to unnecessary burden on the healthcare system and psychological stress for patients.
