Not yet recruitingNCT06546046Updated Aug 14, 2024

Analysis of the Efficacy and Stability of a Wearable ECG Monitor

An interventional study of ECG monitoring by telemetry device and patch-type ECG monitor at the same time in Arrhythmias, Cardiac, Bradycardia and Tachycardia, sponsored by Mezoo Co., Ltd.. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Mezoo Co., Ltd. · Not applicable, Interventional, and Screening

From the registry’s dates

Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Not applicable
Ages: 19 Years and older
Sex: All

Study summary

Read the 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.

Conditions studied

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

Browse trials for

Keywords

Monitoring
Telemetry
Wearable device
Arrhythmia alarm
Signal loss
Satisfaction survey

In context

Arrhythmias, Cardiac

1,051 studies on the registry are indexed under Arrhythmias, Cardiac; 236 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 517 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Mezoo Co., Ltd. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram): A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Study design

Phase: Not applicable
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

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

Interventions

DeviceECG 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 researchers measure

Primary outcomes

The number of total QRS complex
Number of total QRS complex is compared based on the data obtained simultaneously from two devices.
Time frame: 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.
Time frame: Within 3 months after electrocardiogram monitoring procedure

Secondary outcomes

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

Study locations

No study locations are listed for this record.

References and documents

Publications

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. PubMed 33200590 ↗
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. PubMed 38506104 ↗
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. PubMed 28629374 ↗
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. PubMed 30855232 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06546046
Lead sponsor: Mezoo Co., Ltd.
Responsible party: Sponsor
First posted: Aug 9, 2024
Start date: Sep 9, 2024 (estimated)
Primary completion: Dec 30, 2024 (estimated)
Completion: Mar 30, 2025 (estimated)
Last update: Aug 14, 2024

Study contacts

SH Lee

Contact

shlee@me-zoo.com

82-33-761-2006 ext. 412

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Arrhythmias, Cardiac →

Other studies from this sponsor

Mezoo Co., Ltd.

Start the discussion