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

Launched by KARDI AI TECHNOLOGIES S.R.O. · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medical device called Kardi Ai, which is designed to monitor heart rhythms using a technology called ECG (electrocardiogram) telemetry. The goal is to see how safe and effective this device is for detecting various heart rhythm disorders, such as atrial fibrillation and tachycardia. Researchers want to understand how accurately the Kardi Ai device can identify these issues and the quality of the recordings it produces.

To participate in this trial, individuals must be over 18 years old and have either a confirmed or suspected heart rhythm disorder. Participants will need to be able to use a smartphone and the Kardi Ai app, which is necessary for the device to work. During the study, participants will wear the Kardi Ai device for at least 10 hours over a minimum of five days to collect heart rhythm data. This trial is currently recruiting, and it is open to all genders. It's important to note that individuals who are pregnant or have certain skin conditions at the attachment site may not be eligible to participate.

Gender

ALL

Eligibility criteria

• 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