Analysis of the Efficacy and Stability of a Wearable ECG Monitor

Mezoo

Status: Not yet enrolling

Conditions: Bradycardia; Atrial Flutter; Atrial Fibrillation; Tachycardia; Arrhythmias, Cardiac; Ventricular Premature Complexes

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06546046

CDV-2024-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

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