Analysis of the Efficacy and Stability of a Wearable ECG Monitor

NCT06546046 | Not Yet Recruiting

• 1 other identifier: CDV-2024-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• The number of total QRS complex

  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

  Rate of signal loss is compared based on the data obtained simultaneously from two devices.

  Within 3 months after electrocardiogram monitoring procedure

Secondary Outcomes (3)

• Average heart rate

  Within 3 months after electrocardiogram monitoring procedure

• The number of arrhythmia and technical alarm

  Within 3 months after electrocardiogram monitoring procedure

• Results of satisfaction survey

  Within 3 months after electrocardiogram monitoring procedure

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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.

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mezoo Co., Ltd.: lead

Related Publications (4)

• Choi W, Kim SH, Lee W, Kang SH, Yoon CH, Youn TJ, Chae IH. Comparison of Continuous ECG Monitoring by Wearable Patch Device and Conventional Telemonitoring Device. J Korean Med Sci. 2020 Nov 16;35(44):e363. doi: 10.3346/jkms.2020.35.e363.

  PMID: 33200590 BACKGROUND

• Kwon S, Choi EK, Lee SR, Oh S, Song HS, Lee YS, Han SJ, Lim HE. Comparison of Novel Telemonitoring System Using the Single-lead Electrocardiogram Patch With Conventional Telemetry System. Korean Circ J. 2024 Mar;54(3):140-153. doi: 10.4070/kcj.2023.0252.

  PMID: 38506104 BACKGROUND

• Marouf M, Vukomanovic G, Saranovac L, Bozic M. Multi-purpose ECG telemetry system. Biomed Eng Online. 2017 Jun 19;16(1):80. doi: 10.1186/s12938-017-0371-6.

  PMID: 28629374 BACKGROUND

• Nelson BW, Allen NB. Accuracy of Consumer Wearable Heart Rate Measurement During an Ecologically Valid 24-Hour Period: Intraindividual Validation Study. JMIR Mhealth Uhealth. 2019 Mar 11;7(3):e10828. doi: 10.2196/10828.

  PMID: 30855232 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Cardiac Complexes, Premature

Central Study Contacts

SH Lee

CONTACT

82-33-761-2006; shlee@me-zoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: September 9, 2024
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08