Analysis of the Efficacy and Stability of a Wearable ECG Monitor

NCT ID: NCT06546046

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-09

Study Completion Date

2025-03-30

Brief Summary

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This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring

Detailed Description

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This study aims to analyze the efficacy and safety of wearable electrocardiogram (ECG) monitoring by simultaneously attaching a single-channel patch-type wearable ECG monitoring device (HiCardi+ by Mezoo Co., Ltd.) and a telemetry device (IntelliVue MX40 by Philips) used in actual wards to patients prescribed with ECG monitoring. After the data collection is completed, a satisfaction survey will be conducted with the medical staff. The data obtained simultaneously from HiCardi+ and MX40 will be analyzed, and the satisfaction survey responses from the medical staff will be reviewed to confirm the clinical convenience of the patch-type ECG monitoring device.

Conditions

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Arrhythmias, Cardiac Bradycardia Tachycardia Atrial Fibrillation Atrial Flutter Ventricular Premature Complexes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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ECG monitoring by telemetry device and patch-type ECG monitor at the same time

The patient undergoes electrocardiogram monitoring simultaneously through a telemetry device and a patch-type electrocardiograph.

Group Type EXPERIMENTAL

ECG monitoring by telemetry device and patch-type ECG monitor at the same time

Intervention Type DEVICE

The patient undergoes electrocardiogram monitoring simultaneously through a telemetry device and a patch-type electrocardiograph.

Interventions

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ECG monitoring by telemetry device and patch-type ECG monitor at the same time

The patient undergoes electrocardiogram monitoring simultaneously through a telemetry device and a patch-type electrocardiograph.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults aged 19 years or older
2. Patients admitted to Chonnam National University Hospital who require ECG monitoring
3. Individuals who have expressed their intention to participate in this study or have obtained written consent from a proxy

Exclusion Criteria

1. Individuals who are unable to provide consent themselves or through a legally designated representative
2. Individuals deemed unsuitable for participation in the clinical trial based on the researcher's judgment
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mezoo Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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SH Lee

Role: CONTACT

82-33-761-2006 ext. 412

References

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Choi W, Kim SH, Lee W, Kang SH, Yoon CH, Youn TJ, Chae IH. Comparison of Continuous ECG Monitoring by Wearable Patch Device and Conventional Telemonitoring Device. J Korean Med Sci. 2020 Nov 16;35(44):e363. doi: 10.3346/jkms.2020.35.e363.

Reference Type BACKGROUND
PMID: 33200590 (View on PubMed)

Kwon S, Choi EK, Lee SR, Oh S, Song HS, Lee YS, Han SJ, Lim HE. Comparison of Novel Telemonitoring System Using the Single-lead Electrocardiogram Patch With Conventional Telemetry System. Korean Circ J. 2024 Mar;54(3):140-153. doi: 10.4070/kcj.2023.0252.

Reference Type BACKGROUND
PMID: 38506104 (View on PubMed)

Marouf M, Vukomanovic G, Saranovac L, Bozic M. Multi-purpose ECG telemetry system. Biomed Eng Online. 2017 Jun 19;16(1):80. doi: 10.1186/s12938-017-0371-6.

Reference Type BACKGROUND
PMID: 28629374 (View on PubMed)

Nelson BW, Allen NB. Accuracy of Consumer Wearable Heart Rate Measurement During an Ecologically Valid 24-Hour Period: Intraindividual Validation Study. JMIR Mhealth Uhealth. 2019 Mar 11;7(3):e10828. doi: 10.2196/10828.

Reference Type BACKGROUND
PMID: 30855232 (View on PubMed)

Other Identifiers

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CDV-2024-01

Identifier Type: -

Identifier Source: org_study_id

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