Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System
Recruiting
N/A
Interventional Study
Atrial Fibrillation (AF)
Atrial Premature Complexes
Ventricular Premature Complexes
Bradycardia
Tachycardia
Supraventricular Tachycardia
Wide QRS Tachycardia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 115 (estimated)
- Sponsor
- KARDI AI Technologies s.r.o. · Industry
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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 he…
Trial Locations
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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 …
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