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

RecruitingNAAges 18 Years - anyAllKARDI AI Technologies s.r.o.
NCT07018648 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Medical device
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Where

2 sites
Fakultní nemocnice Olomouc
Olomouc, Czechia
Fakultní nemocnice Ostrava
Ostrava, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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