Atrial Fibrillation (AF)Kardi AiNCT07018648
Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
A study testing Medical device in people with Atrial Fibrillation (AF) and Atrial Premature Complexes, run by KARDI AI Technologies s.r.o. at 2 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Premature Complexes, Ventricular Premature Complexes
- What is being tested?
- Medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesCzechia
- Study dates
- 19 May 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites, 2 recruiting
- Recruiting
Fakultní nemocnice Olomouc
Olomouc, Czechia, 779 00
Jan Vácha, MUDr., +420 779 998 100, Jan.vacha@fnol.cz
- Recruiting
Fakultní nemocnice Ostrava
Ostrava, Czechia, 708 52
Jiří Plášek, doc. MUDr. PhD. FESC, +420 779 998 100, jiri.plasek@fno.cz
About this study
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)
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.
Read the detailed description
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:
- Familiarisation of the subject with the clinical trial
- Signing the informed consent
- Handover of the Kardi Ai medical device (packaging hardware components of the Polar H10 chest strap, including instructions for use and QR codes for installation of the Kardi Ai app), registration of the subject in the physician's electronic Case Report Form.
- Installation and commissioning of the mobile pohone application by the subject.
- 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:
- Atrial Fibrillation
- Supraventricular tachycardia
- Wide-complex tachycardia
- Increased number of supraventricular extrasystoles
- Increased number of ventricular extrasystoles
- Tachycardia>220 bpm
- Bradycardia<40 bpm
- KPIs calculated by AI will be automatically transmitted via API to the EDC system, where the results of each measurement will be stored in a separate form under the specific code of the subject.
- Individual ECG recordings will be annotated by the physician. The heart rhythm disorders found in the measurements will be recorded by the physician in the electronic Case Report Form.
- 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.
- Upon completion of the data collection, a questionnaire related to the individual satisfaction with the Kardi Ai system will be completed by each subject of the trial.
- Conditions
- Atrial Fibrillation (AF), Atrial Premature Complexes, Ventricular Premature Complexes, Bradycardia, Tachycardia, Supraventricular Tachycardia
- Being tested
- Medical device
- Keywords
- AI, heart rhythm disorders, ECG, EKG, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation, Atrial Premature Complexes, Ventricular Premature Complexes, Bradycardia, Tachycardia, Tachycardia, Supraventricular, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical deviceDevice
Adding Kardi Ai medical device for detection of heart rythm disorders
| Study group | Role | What they receive |
|---|---|---|
| Group with potential heart rythm disorder | Experimental | Not described Receives: Device: Medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of measurements at 3 weeks
Secondary outcomes (1)
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.
Measured: From enrollment to the end of measurements at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start19 May 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KARDI AI Technologies s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fakultní nemocnice Olomouc, University Hospital Ostrava
- Responsible party
- Sponsor
- Investigators
- Jiří Plášek, doc. MUDr. PhD. FESC, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018648
- Sponsor's protocol ID
- IBA1236
- Acronym
- Kardi Ai
- Status last verified
- Jun 2025
- First submitted
- 17 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07018648
- Acronym / sponsor ID
- Kardi Ai / IBA1236
- Conditions
- Atrial Fibrillation (AF), Atrial Premature Complexes, Ventricular Premature Complexes, Bradycardia, Tachycardia, Supraventricular Tachycardia
- Keywords
- AI, heart rhythm disorders, ECG, EKG, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- KARDI AI Technologies s.r.o.Industry (pharma, biotech, devices)
- Collaborators
- Fakultní nemocnice Olomouc, University Hospital Ostrava
- Study start
- 19 May 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Familiarisation of the subject with the clinical trial
- Signing the informed consent
- Handover of the Kardi Ai medical device (packaging hardware components of the Polar H10 chest strap, including instructions for use and QR codes for installation of the Kardi Ai app), registration of the subject in the physician's electronic Case Report Form.
- Installation and commissioning of the mobile pohone application by the subject.
- 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:
- Atrial Fibrillation
- Supraventricular tachycardia
- Wide-complex tachycardia
- Increased number of supraventricular extrasystoles
- Increased number of ventricular extrasystoles
- Tachycardia>220 bpm
- Bradycardia<40 bpm
- KPIs calculated by AI will be automatically transmitted via API to the EDC system, where the results of each measurement will be stored in a separate form under the specific code of the subject.
- Individual ECG recordings will be annotated by the physician. The heart rhythm disorders found in the measurements will be recorded by the physician in the electronic Case Report Form.
- 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.
- Upon completion of the data collection, a questionnaire related to the individual satisfaction with the Kardi Ai system will be completed by each subject of the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group with potential heart rythm disorder | Experimental | Device: Medical device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical deviceAdding Kardi Ai medical device for detection of heart rythm disorders | Device | Group with potential heart rythm disorder |
Primary outcome
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 and heart rythm disorders.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiří Plášek, doc. MUDr. PhD. FESC principal investigator
University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical device in people with Atrial Fibrillation (AF) and Atrial Premature Complexes, run by KARDI AI Technologies s.r.o. at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Skála (+420 779 998 100, david@kardi.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.