Holter Versus Zio Patch Electrocardiographic Monitoring in Children

Columbia University

Status: Completed

Conditions: Arrhythmias, Cardiac; Heart Block

Treatments: Device: Zio Patch; Device: Holter Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03309956

AAAR5436

Details and patient eligibility

About

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.

Full 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.

Enrollment: 247 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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247 participants in 1 patient group

Holter Monitor and Zio Patch

Other group

Description:

All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.

Treatment:

Device: Holter Monitor

Device: Zio Patch