Clinical trial NCT05756309: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Mezoo Co., Ltd.
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 105
Sex: ALL
Minimum age (years): 29
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

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

Primary outcomes:
measure: Rate of arrhythmia diagnosis between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
timeFrame: Within 3 months after electrocardiogram procedure
measure: Rate of ECG signal concordance between patch-type electrocardiograph and holter device
timeFrame: Within 3 months after electrocardiogram procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: CEO
name: Junghwan Park
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.