Validation of Electrocardiogram Waveform, Heart Rate Accuracy and Arrhythmia Diagnosis Concordance in Patients With Cardiac Arrhythmia Using Single-channel ECG Monitoring Patch and Holter Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mezoo Co., Ltd.
- Enrollment
- 105
- Locations
- 2
- Primary Endpoint
- Comparison of arrhythmia diagnosis concordance rates between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
Study Overview
Brief Summary
This study will verify the 1-channel patch-type ECG's arrhythmia diagnostic concordance rate and electrocardiogram measurement performance by collecting ECG signals from patch-type ECG and Holter device simultaneously for data analysis.
Detailed Description
[How to conduct research] This study targeted adults aged 19 years or older. Written consent is obtained from those who are diagnosed with arrhythmia and need a Holter examination among outpatients or inpatients at the Cardiology Department of Kosin University Gospel Hospital. 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 are diagnosed with arrhythmia and need a Holter examination among outpatients or inpatients at the Cardiology Department.
[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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults 19 years of age or older
- •Patients who are diagnosed with arrhythmia and need regular Holter electrocardiography among outpatients or hospitalized patients at the Department of Cardiology, Kosin University Gospel Hospital
- •Those who gave written consent to this clinical study
- •Able to understand and carry out training and instructions
Exclusion Criteria
- •A person with a physical disability that cannot wear a patch-type electrocardiograph
- •A person suffering from skin disease or functional disorder at the site where the patch-type electrocardiograph will be attached
- •Subjects who cannot read the consent form (illiterate, foreigners, etc.)
- •Patients judged to be unsuitable for participation in this clinical study by the judgment of investigators
Outcomes
Primary Outcomes
Comparison of arrhythmia diagnosis concordance rates between patch-type electrocardiograph and commercial Holter device measurement data by arrhythmia categories
Time Frame: Within 3 months after electrocardiogram procedure
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)
Comparison 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 beat, total atrial ectopic beats, minimum heart rate, maximum heart rate, average heart rate and maximum RR interval
Secondary Outcomes
No secondary outcomes reported