RecruitingNot ApplicableNCT07018648

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

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)

Sponsor

KARDI AI Technologies s.r.o.

Enrollment

115 participants

Start Date

May 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable ECG monitoring device called Kardi Ai — a smart chest belt that connects to a smartphone app — to check whether it is safe and effective at detecting heart rhythm problems. **You may be eligible if...** - You are 18 years or older - You have a confirmed or suspected heart rhythm disorder - You own a smartphone that can run the Kardi Ai app **You may NOT be eligible if...** - You are pregnant - You are allergic to materials commonly used in clothing or textiles - You have a wound or skin irritation on your chest where the belt would be worn Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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