Holter Versus Zio Patch Electrocardiographic Monitoring in Children

Not Applicable

Completed

• Conditions: Arrhythmias, Cardiac; Heart Block
• Interventions: Device: Holter Monitor; Device: Zio Patch

• Registration Number: NCT03309956
• Lead Sponsor: Columbia University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-16
• Study Start: 2017-10-18
• Primary Completion: 2019-10-19
• Study Completion: 2019-10-19
• Results First Submitted: 2021-09-20
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-22
• Last Update Submitted: 2024-05-22
• Results First Posted: 2024-06-18
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

• Any patient under age 22 years who has been referred for ambulatory ECG monitoring at Children's Hospital of New York.

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Exclusion Criteria

• Any known skin allergy or sensitivity to adhesive material.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Holter Monitor and Zio Patch	Holter Monitor	All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.
Holter Monitor and Zio Patch	Zio Patch	All subjects will wear the Holter monitor and Zio patch for a total of 48 hours.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Difference in Detection of Clinically Significant Arrhythmias for the Zio Versus the Holter	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 Outcome Measures

Name	Time	Method
Prevalence of Artifact Detected	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States