Arrhythmias, CardiacNCT05756309
Validation of ECG Waveform and Arrhythmia Diagnosis Concordance for Pediatric Patients Using ECG Monitoring Patch
A study testing Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time in people with Arrhythmias, Cardiac, run by Mezoo Co., Ltd. at 1 site in South Korea.
Trial summary
This study will verify the 1-channel patch-type ECG's arrhythmia diagnostic concordance rate and electrocardiogram measurement performance in pediatric patients by collecting ECG signals from patch-type ECG and Holter device simultaneously for data analysis. Read more about this study
- Who is it for?
- Ages 29 days to 19 years
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jan 2023to 30 Dec 2024
- 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 29 days to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- More than 29 days old and less than 19 years old
- Patients who are need regular Holter electrocardiography among outpatients or hospitalized patients at the Pediatrics, Samsung Medical Center
- Those who gave written consent to this clinical study or obtained the written consent of the legal representative
Who cannot join
- Patients who cannot give consent through the patient ownself or legal representative
- If the researcher judges that participation in this study is inappropriate for other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
J Huh
About this study
Official title: Validation of Electrocardiogram Waveform, Heart Rate Accuracy and Arrhythmia Diagnosis Concordance for Pediatric Patients Using Single-channel ECG Monitoring Patch and Holter Monitoring
This study will verify the 1-channel patch-type ECG's arrhythmia diagnostic concordance rate and electrocardiogram measurement performance in pediatric patients by collecting ECG signals from patch-type ECG and Holter device simultaneously for data analysis.
Read the detailed description
[How to conduct research] This study targeted more than 29 days old and less than 19 years old. Written consent is obtained from those who need a Holter examination among outpatients or inpatients at the Pediatrics of Samsung Medical Center. The medical staff attaches the Holter device to the subject and the patch-type electrocardiograph in the Holter examination room. Holter device and patch-type electrocardiograph are returned to the Holter examination room after measuring the electrocardiogram for 24 hours. ECG signals from patch-type electrocardiographs and commercial Holter device and arrhythmia detection information are compared and analyzed.
[Number of Subjects] The number of this study is 105. Written consent is obtained from those who need a Holter examination among outpatients or inpatients at the Pediatrics.
[Data analysis plan] In this study, the personal identification information of the subjects will be coded non-identifying and the collected electrocardiogram data will be stored in the cloud with restricted access from outsiders. Coded, non-identified research data is stored and managed in the cloud in compliance with privacy standards and information security standards. ECG data transmitted through the mobile application is stored in the cloud. Confidentiality and security of data are guaranteed, and data collected from patch-type electrocardiograph is used only for research. The electrocardiogram data acquired in this study are obtained in TXT or MAT format and used for data analysis.
The efficacy evaluation items are as follows.
- Comparison of ECG signal concordance
- Comparison of the parameters below for a noise-free section of about 1 minute, not the entire section
- P-wave, QRS-complex, T-wave: Sensitivity, Positive Predictive Value, Amplitude difference, Correlation to the entire signal
- P, QRS, T (On/Off time): Time difference
- PR, QRS, QT (Duration/Interval): Time difference
- Comparison of arrhythmia diagnosis concordance rates between 24-hour patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories (total of 19 including ventricular ectopic beat)
The evaluation method and interpretation method are as follows.
- In the case of categorical variables, the sensitivity and positive predictive value are evaluated, and in the case of continuous variables, the concordance between the measured values measured by the patch-type electrocardiograph and the Holter device is evaluated using the Bland-Altman plot.
- Amplitude difference of P-wave, QRS-complex and T-wave \& Correlation to the entire signal
- Peaks of P-wave, QRS-complex (R-wave peaks) and peaks of T-wave are manually annotated in the holter device and patch-type ECG independently to assess amplitude difference and correlation to the entire ECG signal.
- Time difference of P, QRS, T (On/Off time) \& PR, QRS, QT (Duration/Interval)
- Exact timing of fiducial markers such as onset of P-wave and QRS-complex, and offset of P-wave, QRS-complex, T-wave and clinically useful intervals and durations (PR-interval, RR interval, QT interval, P-wave duration, QRS-duration) are manually annotated in the holter device and patch-type ECG independently to quantify the accuracy of delineating these characteristic points in the patch sensor.
- Root Mean Square of Heart Rate
- Calculate and analyze the square root after averaging the squares of each heart rate value in the analysis section from the electrocardiogram obtained simultaneously from the Holter device and the patch-type electrocardiograph
- Conditions
- Arrhythmias, Cardiac
- Being tested
- Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time
- Keywords
- ECG monitoring patch, Validation of Electrocardiogram waveform, Validation of heart rate accuracy, Validation of arrhythmia diagnosis concordance, Patients with cardiac arrhythmia, Holter, Wearable patch-type electrocardiograph
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same timeDevice
The patient is measured electrocardiogram simultaneously through a holter device and patch-type electrocardiograph
| Study group | Role | What they receive |
|---|---|---|
| Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time | Experimental | The patient is measured electrocardiogram simultaneously through a holter device and patch-type electrocardiograph Receives: Device: Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of arrhythmia diagnosis between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
Rate of arrhythmia diagnosis between 24-hour patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories(total of 19 including ventricular ectopic beat)
Measured: Within 3 months after electrocardiogram procedure
Rate of ECG signal concordance between patch-type electrocardiograph and holter device
Calculate the concordance (%) of the ECG signal by comparing and analyzing total QRS complex, total ventricular ectopic beats, total atrial ectopic beats, minimum heart rate(bpm), maximum heart rate(bpm), average heart rate(bpm) and maximum RR interval(ms)
Measured: Within 3 months after electrocardiogram procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start16 Jan 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mezoo Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Junghwan Park, Study director, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756309
- Sponsor's protocol ID
- CDV-2022-02
- Status last verified
- Aug 2024
- First submitted
- 13 Feb 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajbhandary PL, Nallathambi G, Selvaraj N, Tran T, Colliou O. ECG Signal Quality Assessments of a Small Bipolar Single-Lead Wearable Patch Sensor. Cardiovasc Eng Technol. 2022 Oct;13(5):783-796. doi: 10.1007/s13239-022-00617-3. Epub 2022 Mar 15.
PubMed 35292914Kancharla K, Estes NAM. Mobile cardiac monitoring during the COVID-19 pandemic: Necessity is the mother of invention. J Cardiovasc Electrophysiol. 2020 Nov;31(11):2812-2813. doi: 10.1111/jce.14726. Epub 2020 Sep 3. No abstract available.
PubMed 32852854Fung E, Jarvelin MR, Doshi RN, Shinbane JS, Carlson SK, Grazette LP, Chang PM, Sangha RS, Huikuri HV, Peters NS. Electrocardiographic patch devices and contemporary wireless cardiac monitoring. Front Physiol. 2015 May 27;6:149. doi: 10.3389/fphys.2015.00149. eCollection 2015.
PubMed 26074823Kennedy HL. The evolution of ambulatory ECG monitoring. Prog Cardiovasc Dis. 2013 Sep-Oct;56(2):127-32. doi: 10.1016/j.pcad.2013.08.005. Epub 2013 Sep 11.
PubMed 24215744Garson A Jr. Arrhythmias in pediatric patients. Med Clin North Am. 1984 Sep;68(5):1171-210. doi: 10.1016/s0025-7125(16)31091-4.
PubMed 6492933Solomon MD, Yang J, Sung SH, Livingston ML, Sarlas G, Lenane JC, Go AS. Incidence and timing of potentially high-risk arrhythmias detected through long term continuous ambulatory electrocardiographic monitoring. BMC Cardiovasc Disord. 2016 Feb 17;16:35. doi: 10.1186/s12872-016-0210-x.
PubMed 26883019Yenikomshian M, Jarvis J, Patton C, Yee C, Mortimer R, Birnbaum H, Topash M. Cardiac arrhythmia detection outcomes among patients monitored with the Zio patch system: a systematic literature review. Curr Med Res Opin. 2019 Oct;35(10):1659-1670. doi: 10.1080/03007995.2019.1610370. Epub 2019 May 28.
PubMed 31045463
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Electrocardiogram Waveform, Heart Rate Accuracy and Arrhythmia Diagnosis Concordance for Pediatric Patients Using Single-channel ECG Monitoring Patch and Holter Monitoring
- ClinicalTrials.gov ID
- NCT05756309
- Acronym / sponsor ID
- CDV-2022-02
- Conditions
- Arrhythmias, Cardiac
- Keywords
- ECG monitoring patch, Validation of Electrocardiogram waveform, Validation of heart rate accuracy, Validation of arrhythmia diagnosis concordance, Patients with cardiac arrhythmia, Holter, Wearable patch-type electrocardiograph
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mezoo Co., Ltd.University, hospital or other
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 6 Mar 2023 (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 will verify the 1-channel patch-type ECG's arrhythmia diagnostic concordance rate and electrocardiogram measurement performance in pediatric patients by collecting ECG signals from patch-type ECG and Holter device simultaneously for data analysis.
Detailed description
[How to conduct research] This study targeted more than 29 days old and less than 19 years old. Written consent is obtained from those who need a Holter examination among outpatients or inpatients at the Pediatrics of Samsung Medical Center. The medical staff attaches the Holter device to the subject and the patch-type electrocardiograph in the Holter examination room. Holter device and patch-type electrocardiograph are returned to the Holter examination room after measuring the electrocardiogram for 24 hours. ECG signals from patch-type electrocardiographs and commercial Holter device and arrhythmia detection information are compared and analyzed.
[Number of Subjects] The number of this study is 105. Written consent is obtained from those who need a Holter examination among outpatients or inpatients at the Pediatrics.
[Data analysis plan] In this study, the personal identification information of the subjects will be coded non-identifying and the collected electrocardiogram data will be stored in the cloud with restricted access from outsiders. Coded, non-identified research data is stored and managed in the cloud in compliance with privacy standards and information security standards. ECG data transmitted through the mobile application is stored in the cloud. Confidentiality and security of data are guaranteed, and data collected from patch-type electrocardiograph is used only for research. The electrocardiogram data acquired in this study are obtained in TXT or MAT format and used for data analysis.
The efficacy evaluation items are as follows.
- Comparison of ECG signal concordance
- Comparison of the parameters below for a noise-free section of about 1 minute, not the entire section
- P-wave, QRS-complex, T-wave: Sensitivity, Positive Predictive Value, Amplitude difference, Correlation to the entire signal
- P, QRS, T (On/Off time): Time difference
- PR, QRS, QT (Duration/Interval): Time difference
- Comparison of arrhythmia diagnosis concordance rates between 24-hour patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories (total of 19 including ventricular ectopic beat)
The evaluation method and interpretation method are as follows.
- In the case of categorical variables, the sensitivity and positive predictive value are evaluated, and in the case of continuous variables, the concordance between the measured values measured by the patch-type electrocardiograph and the Holter device is evaluated using the Bland-Altman plot.
- Amplitude difference of P-wave, QRS-complex and T-wave \& Correlation to the entire signal
- Peaks of P-wave, QRS-complex (R-wave peaks) and peaks of T-wave are manually annotated in the holter device and patch-type ECG independently to assess amplitude difference and correlation to the entire ECG signal.
- Time difference of P, QRS, T (On/Off time) \& PR, QRS, QT (Duration/Interval)
- Exact timing of fiducial markers such as onset of P-wave and QRS-complex, and offset of P-wave, QRS-complex, T-wave and clinically useful intervals and durations (PR-interval, RR interval, QT interval, P-wave duration, QRS-duration) are manually annotated in the holter device and patch-type ECG independently to quantify the accuracy of delineating these characteristic points in the patch sensor.
- Root Mean Square of Heart Rate
- Calculate and analyze the square root after averaging the squares of each heart rate value in the analysis section from the electrocardiogram obtained simultaneously from the Holter device and the patch-type electrocardiograph
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time | Experimental | Device: Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same timeThe patient is measured electrocardiogram simultaneously through a holter device and patch-type electrocardiograph |
Who may qualify
- Ages
- 29 days to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- More than 29 days old and less than 19 years old
- Patients who are need regular Holter electrocardiography among outpatients or hospitalized patients at the Pediatrics, Samsung Medical Center
- Those who gave written consent to this clinical study or obtained the written consent of the legal representative
Key exclusion criteria (2 listed)
- Patients who cannot give consent through the patient ownself or legal representative
- If the researcher judges that participation in this study is inappropriate for other reasons
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 |
|---|---|---|
| Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same timeThe patient is measured electrocardiogram simultaneously through a holter device and patch-type electrocardiograph | Device | Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time |
Primary outcome
Rate of arrhythmia diagnosis between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
Time frame: Within 3 months after electrocardiogram procedure
Rate of arrhythmia diagnosis between 24-hour patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories(total of 19 including ventricular ectopic beat)
Rate of ECG signal concordance between patch-type electrocardiograph and holter device
Time frame: Within 3 months after electrocardiogram procedure
Calculate the concordance (%) of the ECG signal by comparing and analyzing total QRS complex, total ventricular ectopic beats, total atrial ectopic beats, minimum heart rate(bpm), maximum heart rate(bpm), average heart rate(bpm) and maximum RR interval(ms)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 35292914Rajbhandary PL, Nallathambi G, Selvaraj N, Tran T, Colliou O. ECG Signal Quality Assessments of a Small Bipolar Single-Lead Wearable Patch Sensor. Cardiovasc Eng Technol. 2022 Oct;13(5):783-796. doi: 10.1007/s13239-022-00617-3. Epub 2022 Mar 15.
- Background: PubMed 32852854Kancharla K, Estes NAM. Mobile cardiac monitoring during the COVID-19 pandemic: Necessity is the mother of invention. J Cardiovasc Electrophysiol. 2020 Nov;31(11):2812-2813. doi: 10.1111/jce.14726. Epub 2020 Sep 3. No abstract available.
- Background: PubMed 26074823Fung E, Jarvelin MR, Doshi RN, Shinbane JS, Carlson SK, Grazette LP, Chang PM, Sangha RS, Huikuri HV, Peters NS. Electrocardiographic patch devices and contemporary wireless cardiac monitoring. Front Physiol. 2015 May 27;6:149. doi: 10.3389/fphys.2015.00149. eCollection 2015.
- Background: PubMed 24215744Kennedy HL. The evolution of ambulatory ECG monitoring. Prog Cardiovasc Dis. 2013 Sep-Oct;56(2):127-32. doi: 10.1016/j.pcad.2013.08.005. Epub 2013 Sep 11.
- Background: PubMed 6492933Garson A Jr. Arrhythmias in pediatric patients. Med Clin North Am. 1984 Sep;68(5):1171-210. doi: 10.1016/s0025-7125(16)31091-4.
- Background: PubMed 26883019Solomon MD, Yang J, Sung SH, Livingston ML, Sarlas G, Lenane JC, Go AS. Incidence and timing of potentially high-risk arrhythmias detected through long term continuous ambulatory electrocardiographic monitoring. BMC Cardiovasc Disord. 2016 Feb 17;16:35. doi: 10.1186/s12872-016-0210-x.
- Background: PubMed 31045463Yenikomshian M, Jarvis J, Patton C, Yee C, Mortimer R, Birnbaum H, Topash M. Cardiac arrhythmia detection outcomes among patients monitored with the Zio patch system: a systematic literature review. Curr Med Res Opin. 2019 Oct;35(10):1659-1670. doi: 10.1080/03007995.2019.1610370. Epub 2019 May 28.
- Individual participant dataSharing planned: No
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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.
Junghwan Park study director
CEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrocardiogram measurements by holter device and patch-type electrocardiographic at the same time in people with Arrhythmias, Cardiac, run by Mezoo Co., Ltd. at 1 site in South Korea.
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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Sanghee 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?
Rate of arrhythmia diagnosis between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories (time frame: Within 3 months after electrocardiogram 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 NCT05756309, which also lists 7 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 9 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.