NCT03309956

Holter Versus Zio Patch Electrocardiographic Monitoring in Children

Comparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arrhythmias, Cardiac
• Heart Block

Interventions

Type	Name	Description
DEVICE	Holter Monitor	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.
DEVICE	Zio Patch	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.

Timeline

• Start date: 2017-10-18
• Primary completion: 2019-10-19
• Completion: 2019-10-19
• First posted: 2017-10-16
• Last updated: 2024-06-18
• Results posted: 2024-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study