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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age29-19
SponsorMezoo Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

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

    Device

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

Treatment groups

105 Participants
are divided into 1 treatment group
Group A: Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same timeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of arrhythmia diagnosis between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories

Rate of arrhythmia diagnosis between 24-hour patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories(total of 19 including ventricular ectopic beat)

Time frame
Within 3 months after electrocardiogram procedure
2

Rate of ECG signal concordance between patch-type electrocardiograph and holter device

Calculate the concordance (%) of the ECG signal by comparing and analyzing total QRS complex, total ventricular ectopic beats, total atrial ectopic beats, minimum heart rate(bpm), maximum heart rate(bpm), average heart rate(bpm) and maximum RR interval(ms)

Time frame
Within 3 months after electrocardiogram procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

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