CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 247 enrolled
Drug / intervention
Holter Monitor +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03309956
NCT03309956N/ACompleted
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Comparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children

Columbia University·interventional·Posted Oct 16, 2017·Updated Jun 18, 2024

In Brief

A clinical study evaluating Holter Monitor and Zio Patch for Arrhythmias, Cardiac and Heart Block. Completed, enrolled 247 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArrhythmias, Cardiac, Heart Block
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 16, 2017
Enrollment StartOct 18, 2017
Primary CompletionOct 19, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.7 years ago

Interventions

Holter Monitordevice

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.

Zio Patchdevice

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.