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RECRUITING
NCT07018648
NA

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

Sponsor: KARDI AI Technologies s.r.o.

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2025-05-19

Completion Date

2025-08-30

Last Updated

2025-06-12

Healthy Volunteers

No

Interventions

DEVICE

Medical device

Adding Kardi Ai medical device for detection of heart rythm disorders

Locations (2)

Fakultní nemocnice Olomouc

Olomouc, Czechia, Czechia

Fakultní nemocnice Ostrava

Ostrava, Czechia, Czechia