Holter Versus Zio Patch Electrocardiographic Monitoring in Children

NCT ID: NCT03309956

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-18
• Study Completion Date: 2019-10-19

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.

Conditions

Arrhythmias, Cardiac; Heart Block

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Holter Monitor and Zio Patch

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

Group Type: OTHER

Holter Monitor

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leonardo Liberman, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, Fought AJ, Topol EJ. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. 2014 Jan;127(1):95.e11-7. doi: 10.1016/j.amjmed.2013.10.003. Epub 2013 Oct 15.

Reference Type: BACKGROUND

PMID: 24384108 (View on PubMed)

Bolourchi M, Batra AS. Diagnostic yield of patch ambulatory electrocardiogram monitoring in children (from a national registry). Am J Cardiol. 2015 Mar 1;115(5):630-4. doi: 10.1016/j.amjcard.2014.12.014. Epub 2014 Dec 18.

Reference Type: BACKGROUND

PMID: 25591894 (View on PubMed)

Cheung CC, Kerr CR, Krahn AD. Comparing 14-day adhesive patch with 24-h Holter monitoring. Future Cardiol. 2014 May;10(3):319-22. doi: 10.2217/fca.14.24.

Reference Type: BACKGROUND

PMID: 24976467 (View on PubMed)

Lobodzinski SS. ECG patch monitors for assessment of cardiac rhythm abnormalities. Prog Cardiovasc Dis. 2013 Sep-Oct;56(2):224-9. doi: 10.1016/j.pcad.2013.08.006.

Reference Type: BACKGROUND

PMID: 24215754 (View on PubMed)

Rosenberg MA, Samuel M, Thosani A, Zimetbaum PJ. Use of a noninvasive continuous monitoring device in the management of atrial fibrillation: a pilot study. Pacing Clin Electrophysiol. 2013 Mar;36(3):328-33. doi: 10.1111/pace.12053. Epub 2012 Dec 13.

Reference Type: BACKGROUND

PMID: 23240827 (View on PubMed)

Schreiber D, Sattar A, Drigalla D, Higgins S. Ambulatory cardiac monitoring for discharged emergency department patients with possible cardiac arrhythmias. West J Emerg Med. 2014 Mar;15(2):194-8. doi: 10.5811/westjem.2013.11.18973.

Reference Type: BACKGROUND

PMID: 24672611 (View on PubMed)

Tung CE, Su D, Turakhia MP, Lansberg MG. Diagnostic Yield of Extended Cardiac Patch Monitoring in Patients with Stroke or TIA. Front Neurol. 2015 Jan 12;5:266. doi: 10.3389/fneur.2014.00266. eCollection 2014.

Reference Type: BACKGROUND

PMID: 25628595 (View on PubMed)

Turakhia MP, Hoang DD, Zimetbaum P, Miller JD, Froelicher VF, Kumar UN, Xu X, Yang F, Heidenreich PA. Diagnostic utility of a novel leadless arrhythmia monitoring device. Am J Cardiol. 2013 Aug 15;112(4):520-4. doi: 10.1016/j.amjcard.2013.04.017. Epub 2013 May 11.

Reference Type: BACKGROUND

PMID: 23672988 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AAAR5436

Identifier Type: -

Identifier Source: org_study_id