Validation of ECG Waveform and Arrhythmia Diagnosis Concordance Using ECG Monitoring Patch and Holter Monitoring

NCT05744206 | Completed

• 1 other identifier: CDV-2022-01
• 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 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)

• 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)

  Within 3 months after electrocardiogram procedure

• 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 beat, total atrial ectopic beats, minimum heart rate, maximum heart rate, average heart rate and maximum RR interval

  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

Other: 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 OTHER

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: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 19 years of age or older
• Patients who are diagnosed with arrhythmia and need regular Holter electrocardiography among outpatients or hospitalized patients at the Department of Cardiology, Kosin University Gospel Hospital
• Those who gave written consent to this clinical study
• Able to understand and carry out training and instructions

You may not qualify if:

• A person with a physical disability that cannot wear a patch-type electrocardiograph
• A person suffering from skin disease or functional disorder at the site where the patch-type electrocardiograph will be attached
• Subjects who cannot read the consent form (illiterate, foreigners, etc.)
• Patients judged to be unsuitable for participation in this clinical study by the judgment of investigators

Sponsors & Collaborators

• Mezoo Co., Ltd.: lead

Study Sites (1)

Kosin University Gospel Hospital

Busan, South Korea

Location

Related Publications (8)

• 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

• 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

• 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

• Liu CM, Chang SL, Yeh YH, Chung FP, Hu YF, Chou CC, Hung KC, Chang PC, Liao JN, Chan YH, Lo LW, Wu LS, Lin YJ, Wen MS, Chen SA. Enhanced detection of cardiac arrhythmias utilizing 14-day continuous ECG patch monitoring. Int J Cardiol. 2021 Jun 1;332:78-84. doi: 10.1016/j.ijcard.2021.03.015. Epub 2021 Mar 13.

  PMID: 33727122 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

• 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

• Xia H, Garcia GA, Zhao X. Automatic detection of ECG electrode misplacement: a tale of two algorithms. Physiol Meas. 2012 Sep;33(9):1549-61. doi: 10.1088/0967-3334/33/9/1549. Epub 2012 Aug 17.

  PMID: 22903067 BACKGROUND

• Krahn AD, Klein GJ, Yee R, Skanes AC. Detection of asymptomatic arrhythmias in unexplained syncope. Am Heart J. 2004 Aug;148(2):326-32. doi: 10.1016/j.ahj.2004.01.024.

  PMID: 15309004 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• JH Park

  CEO

  STUDY DIRECTOR

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 6, 2023
• First Posted: February 24, 2023
• Study Start: February 8, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)