An interventional study of Medical device in Atrial Fibrillation (AF), Atrial Premature Complexes and Ventricular Premature Complexes, sponsored by KARDI AI Technologies s.r.o.. Recruiting at 2 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by KARDI AI Technologies s.r.o. · Not applicable, Interventional, and Diagnostic
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:
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.
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:
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.
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:
Once the data collection is complete, the results obtained by the AI and the results from the physician will be compared by a statistician.
The accuracy and correctness of the ECG interpretation will be evaluated between the Kardi Ai system vs. the physician-based ECG annotation.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 115 is below the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with KARDI AI Technologies s.r.o. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Medical device
Adding 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.
Time frame: From enrollment to the end of measurements at 3 weeks
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.
Time frame: From enrollment to the end of measurements at 3 weeks
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).
Time frame: From enrollment to the end of measurements at 3 weeks
Plan to share: No
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Aug 2025, 2 months after the start.
Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 2 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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