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Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
Sponsor: KARDI AI Technologies s.r.o.
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
115
Start Date
2025-05-19
Completion Date
2025-08-30
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
Medical device
Adding Kardi Ai medical device for detection of heart rythm disorders
Locations (2)
Fakultní nemocnice Olomouc
Olomouc, Czechia, Czechia
Fakultní nemocnice Ostrava
Ostrava, Czechia, Czechia