About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Medical device

Treatment groups

115 Participants
are divided into 1 treatment group

Locations

2
Fakultní nemocnice Olomouc779 00, OlomoucCzechia, Czechia
Fakultní nemocnice Ostrava708 52, OstravaCzechia, Czechia

Sponsors and collaborators

KARDI AI Technologies s.r.o.

Lead sponsor

Fakultní nemocnice Olomouc

Collaborator

University Hospital Ostrava

Collaborator