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)

Status: Recruiting
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Contact Information
Primary
David Skála
david@kardi.ai
+420 779 998 100
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2025-08-30
Participants
Target number of participants: 115
Treatments
Experimental: Group with potential heart rythm disorder
Sponsors
Collaborators: Fakultní nemocnice Olomouc, University Hospital Ostrava
Leads: KARDI AI Technologies s.r.o.

This content was sourced from clinicaltrials.gov