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Completed

NCT Number: NCT03309956

Holter Versus Zio Patch 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.

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Key information

Conditions

Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Holter monitor

Device

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 Patch

Device

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.

Primary outcomes

  1. Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter

    Time frame: 48 hours

    The diagnostic yield, or the ability to detect an arrhythmia, will be measured for the Holter monitor and the Zio patch monitor for each patient. The diagnostic yield for each arrhythmia subtype will be determined for each device across all patients and compared in paired statistical analysis (McNemar's test).

Secondary outcomes

  1. Prevalence of Artifact Detected

    Time frame: 48 hours

    The aggregate percent analyzable data of the Holter monitor compared to the Zio Patch across all patients will be calculated using descriptive statistics.

Other outcomes

  1. Percentage of Patients Who Preferred the Zio Over the Holter

    Time frame: 48 hours

    Descriptive statistics will be used to analyze survey results. A one page patient satisfaction survey will be filled out at the end of the 48 hours to compare patient/parental preference and possible adverse reactions for each device.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Comparison of Holter With Leadless Patch Ambulatory Electrocardiographic Monitoring in Children

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2017
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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