Analysis of the Efficacy and Stability of a Wearable ECG Monitor

August 11, 2024 updated by: Mezoo Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mezoo Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 9, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 11, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDV-2024-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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