Holter Versus Zio Patch Electrocardiographic Monitoring in Children

Arrhythmias, Cardiac Clinical Trial

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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Heart Block

• NCT number: NCT03309956
• Study type: Interventional
• Source: Columbia University
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 18, 2017
• Completion date: July 2020