RecruitingNot ApplicableNCT05756309

Validation of ECG Waveform and Arrhythmia Diagnosis Concordance for Pediatric Patients Using ECG Monitoring Patch

Validation of Electrocardiogram Waveform, Heart Rate Accuracy and Arrhythmia Diagnosis Concordance for Pediatric Patients Using Single-channel ECG Monitoring Patch and Holter Monitoring


Sponsor

Mezoo Co., Ltd.

Enrollment

105 participants

Start Date

Jan 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study will verify the 1-channel patch-type ECG's arrhythmia diagnostic concordance rate and electrocardiogram measurement performance in pediatric patients by collecting ECG signals from patch-type ECG and Holter device simultaneously for data analysis.


Eligibility

Min Age: 29 DaysMax Age: 19 Years

Inclusion Criteria3

  • More than 29 days old and less than 19 years old
  • Patients who are need regular Holter electrocardiography among outpatients or hospitalized patients at the Pediatrics, Samsung Medical Center
  • Those who gave written consent to this clinical study or obtained the written consent of the legal representative

Exclusion Criteria2

  • Patients who cannot give consent through the patient ownself or legal representative
  • If the researcher judges that participation in this study is inappropriate for other reasons

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Interventions

DEVICEElectrocardiogram measurements by holter device and patch-type electrocardiographic at the same time

The patient is measured electrocardiogram simultaneously through a holter device and patch-type electrocardiograph


Locations(1)

Samsung Medical Center

Seoul, South Korea

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NCT05756309


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