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

RECRUITINGN/ASponsored by KARDI AI Technologies s.r.o.
Actively Recruiting
PhaseN/A
SponsorKARDI AI Technologies s.r.o.
Started2025-05-19
Est. completion2025-08-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07018648

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions8

Atrial Fibrillation (AF)Atrial Premature ComplexesBradycardiaHeart DiseaseSupraventricular TachycardiaTachycardiaVentricular Premature ComplexesWide QRS Tachycardia

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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