Analysis of the Efficacy and Stability of a Wearable ECG Monitor

Not Applicable

Not yet recruiting

• Conditions: Arrhythmias, Cardiac; Tachycardia; Ventricular Premature Complexes; Atrial Fibrillation; Bradycardia; Atrial Flutter
• Interventions: Device: ECG monitoring by telemetry device and patch-type ECG monitor at the same time

• Registration Number: NCT06546046
• Lead Sponsor: Mezoo Co., Ltd.

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Submitted: 2024-08-11
• Last Update Posted: 2024-08-14
• Study Start: 2024-09-09
• Primary Completion: 2024-12-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECG monitoring by telemetry device and patch-type ECG monitor at the same time	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.

Primary Outcome Measures

Name	Time	Method
The number of total QRS complex	Within 3 months after electrocardiogram monitoring procedure	Number of total QRS complex is compared based on the data obtained simultaneously from two devices.
The rate of signal loss	Within 3 months after electrocardiogram monitoring procedure	Rate of signal loss is compared based on the data obtained simultaneously from two devices.

Secondary Outcome Measures

Name	Time	Method
Average heart rate	Within 3 months after electrocardiogram monitoring procedure	Average heart rate is compared based on the data obtained simultaneously from two devices.
The number of arrhythmia and technical alarm	Within 3 months after electrocardiogram monitoring procedure	Number of arrhythmia and technical alarm is compared based on the data obtained simultaneously from two devices.
Results of satisfaction survey	Within 3 months after electrocardiogram monitoring procedure	Satisfaction survey responses from the medical staff