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NCT Number: NCT07018648

Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Atrial Premature Complexes Bradycardia Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Supraventricular Tachycardia Tachycardia Tachycardia, Supraventricular Ventricular Premature Complexes Wide QRS Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fakultní nemocnice Olomouc, Olomouc, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Device

Device

Adding Kardi Ai medical device for detection of heart rythm disorders

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 sensitivity and specificity of Kardi Ai across all measurements for each monitored heart rythm disorders.

Other outcomes

  1. Evaluation of the quality of ECG measurements

    Time frame: From enrollment to the end of measurements at 3 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

David Skála

CONTACT

[email protected]

+420 779 998 100

Sponsors and collaborators

Lead sponsor

KARDI AI Technologies s.r.o.

Industry

Collaborators

  • Fakultní nemocnice Olomouc
  • University Hospital Ostrava

Registry information

Official study 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)

Acronym: Kardi Ai

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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