Completed

Comparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children

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What is being tested

Holter Monitor

+ Zio Patch

Device
Who is being recruted

Cardiac Conduction System Disease+4

+ Arrhythmias, Cardiac

+ Cardiovascular Diseases

Until 21 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: October 2017
See protocol details

Summary

Principal SponsorColumbia University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 18, 2017

Actual date on which the first participant was enrolled.

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.

Official TitleComparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children
NCT03309956
Principal SponsorColumbia University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

247 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiac Conduction System DiseaseArrhythmias, CardiacCardiovascular DiseasesHeart BlockHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

1 inclusion criteria required to participate
Any patient under age 22 years who has been referred for ambulatory ECG monitoring at Children's Hospital of New York.

1 exclusion criteria prevent from participating
Any known skin allergy or sensitivity to adhesive material.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Columbia University Medical Center

New York, United StatesOpen Columbia University Medical Center in Google Maps
CompletedOne Study Center