Holter Versus Zio Patch Electrocardiographic Monitoring in Children

Study Overview
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Brief Summary
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This prospective study aims to compare the diagnostic yield, or ability to detect an arrhythmia, of the traditional Holter monitor versus the novel Zio patch monitor in pediatric patients referred for ambulatory electrocardiographic (ECG) monitoring. Children will wear both devices simultaneously for 48 hours and the incidence of clinically significant arrhythmias will be compared.

Detailed Description
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Patients under age 22 years at Children's Hospital of New York (CHONY) who are referred for ambulatory ECG monitoring will be consented and enrolled prospectively to have the Holter monitor and the Zio patch placed simultaneously in the pediatric cardiology clinic. Patients will be instructed to wear both devices for 48 hours. Demographic data will be collected, including date of birth, age, gender, weight, height, chest circumference, body surface area, indication for ambulatory ECG monitoring, prior congenital heart disease, prior cardiac surgery, and prior Holter or Zio patch use. A patient satisfaction survey will be given to the patient and parent/guardian after completion of the study to compare the comfort, interference with daily activities, adverse events (such as skin irritation or if either device fell off), and preference for each device. Holter monitors will be returned to the clinic along with the patient satisfaction survey, and the Zio patch will be mailed back to manufacturer headquarters and the report will be returned to the investigators.

Official Title
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Comparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children

Conditions
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Arrhythmias, Cardiac, Heart Block

Intervention / Treatment
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* Device: Holter Monitor
* Device: Zio Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient under age 22 years who has been referred for ambulatory ECG monitoring at Children's Hospital of New York. Exclusion Criteria: Any known skin allergy or sensitivity to adhesive material.

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All patients will receive the same intervention, namely both devices at the same time for 48 hours.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Holter Monitor and Zio Patch<br>All subjects will wear the Holter monitor and Zio patch for a total of 48 hours. | Device: Holter Monitor<br>* A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours.<br>Device: Zio Patch<br>* The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Yield | The diagnostic yield, or the ability to detect an arrhythmia, will be measured for the Holter monitor and the Zio patch monitor for each patient. The diagnostic yield for each arrhythmia subtype will be determined for each device across all patients and compared in paired statistical analysis (McNemar's test). | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in minimum heart rate recorded | The minimum heart rate recorded using the Holter monitor will be compared to the minimum heart rate recorded using the Zio patch monitor averaged across all patients used paired t-test. | 48 hours | 
| Difference in the maximum heart rate recorded | The maximum heart rate recorded using the Holter monitor will be compared to the maximum heart rate recorded using the Zio patch monitor averaged across all patients used paired t-test. | 48 hours | 
| Average heart rate recorded | The average heart rate recorded using the Holter monitor will be compared to the average heart rate recorded using the Zio patch monitor averaged across all patients used paired t-test. | 48 hours | 
| Aggregate Percent Analyzable Data | The aggregate percent analyzable data of the Holter monitor compared to the Zio Patch across all patients will be calculated using descriptive statistics. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zio Patch Monitor, Ambulatory Electrocardiography, Holter Monitor, Pediatrics