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.
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
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
Single group
Medical device
DeviceAdding Kardi Ai medical device for detection of heart rythm disorders
Evaluation of sensitivity and specificity of Kardi Ai across all measurements and heart rythm disorders.
Evaluation of sensitivity and specificity of Kardi Ai across all measurements and heart rythm disorders.
Evaluation of sensitivity and specificity of Kardi Ai across all measurements for each monitored heart rythm disorders.
Evaluation of sensitivity and specificity of Kardi Ai across all measurements for each monitored heart rythm disorders.
Evaluation of the quality of ECG measurements
Evaluation of the quality of ECG measurements. ECG will be evaluated by physician annotator, who will adjudicate the quality of the ECG on the three point scale. 1 - excellent(above 90% QRS recognizable), 2- medium(above 70% QRS recognizable), 3 - poor(less than 70% QRS recognizable).
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KARDI AI Technologies s.r.o.
Lead sponsor
Fakultní nemocnice Olomouc
Collaborator
University Hospital Ostrava
Collaborator
