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

NCT05756309 | Recruiting

• 1 other identifier: CDV-2022-02
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

  Within 3 months after electrocardiogram procedure

• 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)

  Within 3 months after electrocardiogram procedure

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

Eligibility Criteria

• Age: 29 Days - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mezoo Co., Ltd.: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (7)

• 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.

  PMID: 35292914 BACKGROUND

• 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.

  PMID: 32852854 BACKGROUND

• 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.

  PMID: 26074823 BACKGROUND

• 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.

  PMID: 24215744 BACKGROUND

• 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.

  PMID: 6492933 BACKGROUND

• 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.

  PMID: 26883019 BACKGROUND

• 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.

  PMID: 31045463 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Junghwan Park

  CEO

  STUDY DIRECTOR

Central Study Contacts

Sanghee Lee

CONTACT

82-33-761-2006; shlee@me-zoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 6, 2023
• Study Start: January 16, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)