Arrhythmias, CardiacNCT06546046
Analysis of the Efficacy and Stability of a Wearable ECG Monitor
A study testing ECG monitoring by telemetry device and patch-type ECG monitor at the same time in people with Arrhythmias, Cardiac and Bradycardia, run by Mezoo Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arrhythmias, Cardiac, Bradycardia, Tachycardia
- What is being tested?
- ECG monitoring by telemetry device and patch-type ECG monitor at the same time
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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
- Arrhythmias, Cardiac, Bradycardia, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Premature Complexes
- Being tested
- ECG monitoring by telemetry device and patch-type ECG monitor at the same time
- Keywords
- Monitoring, Telemetry, Wearable device, Arrhythmia alarm, Signal loss, Satisfaction survey
- Medical subject headings
- Arrhythmias, Cardiac, Bradycardia, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG monitoring by telemetry device and patch-type ECG monitor at the same timeDevice
The patient undergoes electrocardiogram monitoring simultaneously through a telemetry device and a patch-type electrocardiograph.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ECG monitoring by telemetry device and patch-type ECG monitor at the same time |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of total QRS complex
Number of total QRS complex is compared based on the data obtained simultaneously from two devices.
Measured: 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.
Measured: Within 3 months after electrocardiogram monitoring procedure
Secondary outcomes (3)
Average heart rate
Average heart rate is compared based on the data obtained simultaneously from two devices.
Measured: 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.
Measured: Within 3 months after electrocardiogram monitoring procedure
Results of satisfaction survey
Satisfaction survey responses from the medical staff
Measured: Within 3 months after electrocardiogram monitoring procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start9 Sep 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mezoo Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546046
- Sponsor's protocol ID
- CDV-2024-01
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33200590Kwon 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 38506104Marouf 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 28629374Nelson 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Efficacy and Stability of a Single-Channel Patch-Type Wearable Electrocardiogram Monitor
- ClinicalTrials.gov ID
- NCT06546046
- Acronym / sponsor ID
- CDV-2024-01
- Conditions
- Arrhythmias, Cardiac, Bradycardia, Tachycardia, Atrial Fibrillation, Atrial Flutter, Ventricular Premature Complexes
- Keywords
- Monitoring, Telemetry, Wearable device, Arrhythmia alarm, Signal loss, Satisfaction survey
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mezoo Co., Ltd.University, hospital or other
- Study start
- 9 Sep 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECG monitoring by telemetry device and patch-type ECG monitor at the same time | Experimental | Device: ECG monitoring by telemetry device and patch-type ECG monitor at the same timeThe patient undergoes electrocardiogram monitoring simultaneously through a telemetry device and a patch-type electrocardiograph. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG monitoring by telemetry device and patch-type ECG monitor at the same timeThe 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 |
Primary outcome
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.
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.
3 secondary outcomes
Average heart rate
Time frame: Within 3 months after electrocardiogram monitoring procedure
The number of arrhythmia and technical alarm
Time frame: Within 3 months after electrocardiogram monitoring procedure
Results of satisfaction survey
Time frame: Within 3 months after electrocardiogram monitoring procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Background: PubMed 33200590Choi 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.
- Background: PubMed 38506104Kwon 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.
- Background: PubMed 28629374Marouf 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.
- Background: PubMed 30855232Nelson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing ECG monitoring by telemetry device and patch-type ECG monitor at the same time in people with Arrhythmias, Cardiac and Bradycardia, run by Mezoo Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SH Lee (82-33-761-2006 ext. 412, shlee@me-zoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of total QRS complex (time frame: Within 3 months after electrocardiogram monitoring procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546046, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.