Holter Versus Zio Patch Electrocardiographic Monitoring in Children



Status:Enrolling by invitation
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 21
Updated:2/7/2019
Start Date:October 18, 2017
End Date:July 2020

Use our guide to learn which trials are right for you!

Comparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children

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.

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.

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.
We found this trial at
1
site
630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
?
mi
from
New York, NY
Click here to add this to my saved trials