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

August 6, 2024 updated by: Mezoo Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

[How to conduct research] This study targeted more than 29 days old and less than 19 years old. Written consent is obtained from those who need a Holter examination among outpatients or inpatients at the Pediatrics of Samsung Medical Center. The medical staff attaches the Holter device to the subject and the patch-type electrocardiograph in the Holter examination room. Holter device and patch-type electrocardiograph are returned to the Holter examination room after measuring the electrocardiogram for 24 hours. ECG signals from patch-type electrocardiographs and commercial Holter device and arrhythmia detection information are compared and analyzed.

[Number of Subjects] The number of this study is 105. Written consent is obtained from those who need a Holter examination among outpatients or inpatients at the Pediatrics.

[Data analysis plan] In this study, the personal identification information of the subjects will be coded non-identifying and the collected electrocardiogram data will be stored in the cloud with restricted access from outsiders. Coded, non-identified research data is stored and managed in the cloud in compliance with privacy standards and information security standards. ECG data transmitted through the mobile application is stored in the cloud. Confidentiality and security of data are guaranteed, and data collected from patch-type electrocardiograph is used only for research. The electrocardiogram data acquired in this study are obtained in TXT or MAT format and used for data analysis.

The efficacy evaluation items are as follows.

  1. Comparison of ECG signal concordance

  2. Comparison of the parameters below for a noise-free section of about 1 minute, not the entire section

    • P-wave, QRS-complex, T-wave: Sensitivity, Positive Predictive Value, Amplitude difference, Correlation to the entire signal
    • P, QRS, T (On/Off time): Time difference
    • PR, QRS, QT (Duration/Interval): Time difference
  3. Comparison of arrhythmia diagnosis concordance rates between 24-hour patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories (total of 19 including ventricular ectopic beat)

The evaluation method and interpretation method are as follows.

  1. In the case of categorical variables, the sensitivity and positive predictive value are evaluated, and in the case of continuous variables, the concordance between the measured values measured by the patch-type electrocardiograph and the Holter device is evaluated using the Bland-Altman plot.

  2. Amplitude difference of P-wave, QRS-complex and T-wave & Correlation to the entire signal

    • Peaks of P-wave, QRS-complex (R-wave peaks) and peaks of T-wave are manually annotated in the holter device and patch-type ECG independently to assess amplitude difference and correlation to the entire ECG signal.

  3. Time difference of P, QRS, T (On/Off time) & PR, QRS, QT (Duration/Interval)

    • Exact timing of fiducial markers such as onset of P-wave and QRS-complex, and offset of P-wave, QRS-complex, T-wave and clinically useful intervals and durations (PR-interval, RR interval, QT interval, P-wave duration, QRS-duration) are manually annotated in the holter device and patch-type ECG independently to quantify the accuracy of delineating these characteristic points in the patch sensor.

  4. Root Mean Square of Heart Rate

    • Calculate and analyze the square root after averaging the squares of each heart rate value in the analysis section from the electrocardiogram obtained simultaneously from the Holter device and the patch-type electrocardiograph

Study Type

Interventional

Enrollment (Estimated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • J Huh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrocardiogram 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
Device: Electrocardiogram 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of arrhythmia diagnosis between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
Time Frame: Within 3 months after electrocardiogram procedure
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)
Within 3 months after electrocardiogram procedure
Rate of ECG signal concordance between patch-type electrocardiograph and holter device
Time Frame: Within 3 months after electrocardiogram procedure
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)
Within 3 months after electrocardiogram procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mezoo Co., Ltd.

Investigators

  • Study Director: Junghwan Park, CEO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

February 13, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDV-2022-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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