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

Study acronym: Kardi Ai
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 12, 2025 (before its estimated August 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07018648
Lead Sponsor KARDI AI Technologies s.r.o.
Collaborators: Fakultní nemocnice Olomouc, University Hospital Ostrava
Conditions
(from sponsor)		 Atrial Fibrillation (AF), Atrial Premature Complexes, Ventricular Premature Complexes, Bradycardia, Tachycardia, Supraventricular Tachycardia, Wide QRS Tachycardia
Related terms Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Premature Complexes, Bradycardia, Tachycardia, Tachycardia, Supraventricular, Ventricular Premature Complexes
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov