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NCT Number: NCT06546046

Analysis of the Efficacy and Stability of a Wearable ECG 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

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Key information

Conditions

Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Bradycardia Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Ventricular Premature Complexes

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Results of satisfaction survey

    Time frame: Within 3 months after electrocardiogram monitoring procedure

    Satisfaction survey responses from the medical staff

Study contacts

Contact information is provided by the study sponsor or research team.

SH Lee

CONTACT

[email protected]

82-33-761-2006 ext. 412

Sponsors and collaborators

Lead sponsor

Mezoo Co., Ltd.

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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