search
Back to results

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

Primary Purpose

Arrhythmias, Cardiac

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time
Sponsored by
Mezoo Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmias, Cardiac focused on measuring ECG monitoring patch, Validation of Electrocardiogram waveform, Validation of heart rate accuracy, Validation of arrhythmia diagnosis concordance, Patients with cardiac arrhythmia, Holter, Wearable patch-type electrocardiograph

Eligibility Criteria

29 Days - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Comparison of arrhythmia diagnosis concordance rates between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
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)
Comparison 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)

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
February 23, 2023
Sponsor
Mezoo Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05756309
Brief Title
Validation of ECG Waveform and Arrhythmia Diagnosis Concordance for Pediatric Patients Using ECG Monitoring Patch
Official Title
Validation of Electrocardiogram Waveform, Heart Rate Accuracy and Arrhythmia Diagnosis Concordance for Pediatric Patients Using Single-channel ECG Monitoring Patch and Holter Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 16, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mezoo Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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. Comparison of ECG signal concordance 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 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. 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. 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. 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac
Keywords
ECG monitoring patch, Validation of Electrocardiogram waveform, Validation of heart rate accuracy, Validation of arrhythmia diagnosis concordance, Patients with cardiac arrhythmia, Holter, Wearable patch-type electrocardiograph

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time
Arm Type
Experimental
Arm Description
The patient is measured electrocardiogram simultaneously through a holter device and patch-type electrocardiograph
Intervention Type
Device
Intervention Name(s)
Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time
Intervention Description
The patient is measured electrocardiogram simultaneously through a holter device and patch-type electrocardiograph
Primary Outcome Measure Information:
Title
Comparison of arrhythmia diagnosis concordance rates between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
Description
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)
Time Frame
Within 3 months after electrocardiogram procedure
Title
Comparison of ECG signal concordance between patch-type electrocardiograph and holter device
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanghee Lee
Phone
82-33-761-2006
Ext
412
Email
shlee@me-zoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junghwan Park
Organizational Affiliation
CEO
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Huh

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35292914
Citation
Rajbhandary PL, Nallathambi G, Selvaraj N, Tran T, Colliou O. ECG Signal Quality Assessments of a Small Bipolar Single-Lead Wearable Patch Sensor. Cardiovasc Eng Technol. 2022 Oct;13(5):783-796. doi: 10.1007/s13239-022-00617-3. Epub 2022 Mar 15.
Results Reference
background
PubMed Identifier
32852854
Citation
Kancharla K, Estes NAM. Mobile cardiac monitoring during the COVID-19 pandemic: Necessity is the mother of invention. J Cardiovasc Electrophysiol. 2020 Nov;31(11):2812-2813. doi: 10.1111/jce.14726. Epub 2020 Sep 3. No abstract available.
Results Reference
background
PubMed Identifier
26074823
Citation
Fung E, Jarvelin MR, Doshi RN, Shinbane JS, Carlson SK, Grazette LP, Chang PM, Sangha RS, Huikuri HV, Peters NS. Electrocardiographic patch devices and contemporary wireless cardiac monitoring. Front Physiol. 2015 May 27;6:149. doi: 10.3389/fphys.2015.00149. eCollection 2015.
Results Reference
background
PubMed Identifier
24215744
Citation
Kennedy HL. The evolution of ambulatory ECG monitoring. Prog Cardiovasc Dis. 2013 Sep-Oct;56(2):127-32. doi: 10.1016/j.pcad.2013.08.005. Epub 2013 Sep 11.
Results Reference
background
PubMed Identifier
6492933
Citation
Garson A Jr. Arrhythmias in pediatric patients. Med Clin North Am. 1984 Sep;68(5):1171-210. doi: 10.1016/s0025-7125(16)31091-4.
Results Reference
background
PubMed Identifier
26883019
Citation
Solomon MD, Yang J, Sung SH, Livingston ML, Sarlas G, Lenane JC, Go AS. Incidence and timing of potentially high-risk arrhythmias detected through long term continuous ambulatory electrocardiographic monitoring. BMC Cardiovasc Disord. 2016 Feb 17;16:35. doi: 10.1186/s12872-016-0210-x.
Results Reference
background
PubMed Identifier
31045463
Citation
Yenikomshian M, Jarvis J, Patton C, Yee C, Mortimer R, Birnbaum H, Topash M. Cardiac arrhythmia detection outcomes among patients monitored with the Zio patch system: a systematic literature review. Curr Med Res Opin. 2019 Oct;35(10):1659-1670. doi: 10.1080/03007995.2019.1610370. Epub 2019 May 28.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs