Validation of ECG monitoring patch for pediatric arrhythmia diagnosis
Validation of Electrocardiogram Waveform, Heart Rate Accuracy and Arrhythmia Diagnosis Concordance for Pediatric Patients Using Single-channel ECG Monitoring Patch and Holter Monitoring
NA · Mezoo Co., Ltd. · NCT05756309
This study is testing a new patch that monitors heart rhythms to see if it can accurately detect arrhythmias in children compared to a standard heart monitor.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 29 Days to 19 Years |
| Sex | All |
| Sponsor | Mezoo Co., Ltd. (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05756309 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the diagnostic accuracy of a 1-channel patch-type ECG in detecting arrhythmias in pediatric patients. It involves simultaneous ECG signal collection from both the patch-type ECG and a Holter device over a 24-hour period. The study will analyze the concordance of arrhythmia diagnoses and the performance of the electrocardiogram measurements. Participants will include outpatients and inpatients at Samsung Medical Center who require Holter examinations, with data securely stored and managed in compliance with privacy standards.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged between 29 days and 19 years who require regular Holter electrocardiography.
Not a fit: Patients who cannot provide consent or are deemed inappropriate for participation by the researcher may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of arrhythmia diagnosis in pediatric patients, leading to better management and treatment outcomes.
How similar studies have performed: Other studies have shown promise in using wearable ECG devices for arrhythmia detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Sanghee Lee
- Email: shlee@me-zoo.com
- Phone: 82-33-761-2006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Arrhythmias, Cardiac, 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