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Holter Versus Zio Patch Electrocardiographic Monitoring in Children

NCT03309956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2024-06-18

Study results available
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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.

Conditions

  • Arrhythmias, Cardiac
  • Heart Block

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Leonardo Liberman, MD · Columbia University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2019-10-19
Completion
2019-10-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03309956 on ClinicalTrials.gov