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Analysis of the Efficacy and Stability of a Wearable ECG Monitor

Analysis of the Efficacy and Stability of a Single-Channel Patch-Type Wearable Electrocardiogram Monitor

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06546046
Enrollment
100
Registered
2024-08-09
Start date
2024-09-09
Completion date
2025-03-30
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Monitoring, Telemetry, Wearable device, Arrhythmia alarm, Signal loss, Satisfaction survey

Brief summary

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

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.

Interventions

DEVICEECG 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.

Sponsors

Mezoo Co., Ltd.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The number of total QRS complexWithin 3 months after electrocardiogram monitoring procedureNumber of total QRS complex is compared based on the data obtained simultaneously from two devices.
The rate of signal lossWithin 3 months after electrocardiogram monitoring procedureRate of signal loss is compared based on the data obtained simultaneously from two devices.

Secondary

MeasureTime frameDescription
Average heart rateWithin 3 months after electrocardiogram monitoring procedureAverage heart rate is compared based on the data obtained simultaneously from two devices.
The number of arrhythmia and technical alarmWithin 3 months after electrocardiogram monitoring procedureNumber of arrhythmia and technical alarm is compared based on the data obtained simultaneously from two devices.
Results of satisfaction surveyWithin 3 months after electrocardiogram monitoring procedureSatisfaction survey responses from the medical staff

Contacts

Primary ContactSH Lee
shlee@me-zoo.com82-33-761-2006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026