Kardi Ai ECG telemetry monitoring for detecting heart rhythm problems
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)
Run by KARDI AI Technologies s.r.o. · NCT07018648 · Data updated 2026-11-12
The Kardi Ai wearable ECG system will be tested to see if it can accurately detect irregular heart rhythms in adults with or suspected of having heart rhythm disorders.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 115 (estimated) |
| Sponsor | KARDI AI Technologies s.r.o. Industry-sponsored |
| Locations | 2 sites (Olomouc, Czechia and 1 other locations) |
| Status | Recruiting |
| Started | May 19, 2025 |
| Main results expected | August 1, 2025 |
| Study ends | August 30, 2025 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT07018648 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with confirmed or suspected heart rhythm disorders who can use a compatible smartphone and wear a chest-strap ECG sensor are the ideal candidates.
✕Probably not a fit
People who cannot operate a smartphone, have skin reactions at the chest strap site, are pregnant, or who need implantable monitoring rather than external ECGs are unlikely to benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants are given the Kardi Ai system (Polar H10 chest strap plus mobile app) to record ECGs at home on at least five different days, totaling at least 10 hours of data with measurements typically done three times per week for two hours each. Recorded ECGs are uploaded to the Kardi Ai cloud and analyzed by the device's AI algorithm, with results compared to expert cardiologist interpretation as the reference standard. The study will report diagnostic test statistics (sensitivity, specificity, predictive values) across all targeted rhythm disorders and for each disorder separately, and will also rate ECG recording quality. Inclusion requires adults able to use a smartphone and the app; key exclusions include pregnancy and skin problems at the chest strap site.
Why it matters
Potential benefit: If successful, Kardi Ai could allow earlier, more convenient detection of atrial fibrillation and other arrhythmias from home, enabling faster clinical follow-up and treatment.
How similar studies have gone: Previous studies of wearable ECG devices and AI algorithms have shown promising accuracy for atrial fibrillation detection, though performance varies by device, recording quality, and rhythm type.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * The subject's mobile phone meets the minimum requirements for the Kardi Ai app to work Exclusion Criteria: * 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
Where it's running
-
Fakultní nemocnice Olomouc
Olomouc, Czechia, Czechia Recruiting -
Fakultní nemocnice Ostrava
Ostrava, Czechia, Czechia Recruiting
Study contacts
- Principal investigator: Jiří Plášek, doc. MUDr. PhD. FESC — University Hospital Ostrava
- Study coordinator: David Skála
- Email: david@kardi.ai
- Phone: +420 779 998 100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.