Comparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmias, Cardiac
- Sponsor
- Columbia University
- Enrollment
- 247
- Locations
- 1
- Primary Endpoint
- Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter
Time Frame: 48 hours
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).
Secondary Outcomes
- Prevalence of Artifact Detected(48 hours)