Holter Versus Zio Patch Electrocardiographic Monitoring in Children

Last updated: May 22, 2024
Sponsor: Columbia University
Overall Status: Completed

Phase

N/A

Condition

Heart Defect

Arrhythmia

Circulation Disorders

Treatment

Zio Patch

Holter Monitor

Clinical Study ID

NCT03309956
AAAR5436
  • Ages < 21
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any patient under age 22 years who has been referred for ambulatory ECG monitoringat Children's Hospital of New York.

Exclusion

Exclusion Criteria:

  • Any known skin allergy or sensitivity to adhesive material.

Study Design

Total Participants: 247
Treatment Group(s): 2
Primary Treatment: Zio Patch
Phase:
Study Start date:
October 18, 2017
Estimated Completion Date:
October 19, 2019

Study 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.

Connect with a study center

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

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