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

NCT07018648 | Recruiting DMC

• 1 other identifier: IBA1236
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Atrial Fibrillation (AF); Atrial Premature Complexes; Ventricular Premature Complexes; Bradycardia; Tachycardia; Supraventricular Tachycardia; Wide QRS Tachycardia

Keywords

AI; heart rhythm disorders; ECG; EKG; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  From enrollment to the end of measurements at 3 weeks

Other Outcomes (1)

• Evaluation of the quality of ECG measurements

  From enrollment to the end of measurements at 3 weeks

Study Arms (1)

Group with potential heart rythm disorder

EXPERIMENTAL

Device: Medical device

Interventions

Medical device DEVICE

Adding Kardi Ai medical device for detection of heart rythm disorders

Group with potential heart rythm disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KARDI AI Technologies s.r.o.: lead
• Fakultní nemocnice Olomouc: collaborator
• University Hospital Ostrava: collaborator

Study Sites (2)

Fakultní nemocnice Olomouc

Olomouc, Czechia, 779 00, Czechia

RECRUITING

Fakultní nemocnice Ostrava

Ostrava, Czechia, 708 52, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Premature Complexes; Ventricular Premature Complexes; Bradycardia; Tachycardia; Tachycardia, Supraventricular; Arrhythmias, Cardiac

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature; Cardiac Conduction System Disease

Study Officials

• Jiří Plášek, doc. MUDr. PhD. FESC

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Skála

CONTACT

+420 779 998 100; david@kardi.ai

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: June 12, 2025
• Study Start: May 19, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 30, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)