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

NCT07018648 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)
  • Atrial Premature Complexes
  • Ventricular Premature Complexes
  • Bradycardia
  • Tachycardia
  • Supraventricular Tachycardia
  • Wide QRS Tachycardia

Interventions

DEVICE

Medical device

Adding Kardi Ai medical device for detection of heart rythm disorders

Sponsors & Collaborators

  • Fakultní nemocnice Olomouc

    collaborator UNKNOWN

  • University Hospital Ostrava

    collaborator OTHER

  • KARDI AI Technologies s.r.o.

    lead INDUSTRY

Principal Investigators

  • Jiří Plášek, doc. MUDr. PhD. FESC · University Hospital Ostrava

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2025-08-01
Completion
2025-08-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018648 on ClinicalTrials.gov