Holter Versus Zio Patch Electrocardiographic Monitoring in Children

NCT03309956 | Completed Results FDA Device

• 1 other identifier: AAAR5436
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmias, Cardiac; Heart Block

Keywords

Ambulatory Electrocardiography; Holter Monitor; Zio Patch Monitor; Pediatrics

Outcome Measures

Primary Outcomes (1)

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

  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).

  48 hours

Secondary Outcomes (1)

• Prevalence of Artifact Detected

  48 hours

Other Outcomes (1)

• Percentage of Patients Who Preferred the Zio Over the Holter

  48 hours

Study Arms (1)

Holter Monitor and Zio Patch

OTHER

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

Device: Holter Monitor; Device: Zio Patch

Interventions

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.

Holter Monitor and Zio Patch

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.

Holter Monitor and Zio Patch

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any known skin allergy or sensitivity to adhesive material.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (8)

• 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.

  PMID: 24384108 BACKGROUND

• 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.

  PMID: 25591894 BACKGROUND

• 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.

  PMID: 24976467 BACKGROUND

• 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.

  PMID: 24215754 BACKGROUND

• 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.

  PMID: 23240827 BACKGROUND

• 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.

  PMID: 24672611 BACKGROUND

• 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.

  PMID: 25628595 BACKGROUND

• 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.

  PMID: 23672988 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Block

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Results Point of Contact

• Title: Leonardo Liberman, MD
• Organization: Columbia University

ll202@cumc.columbia.edu

212-305-8509

Study Officials

• Leonardo Liberman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will receive the same intervention, namely both devices at the same time for 48 hours.

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 16, 2017
• Study Start: October 18, 2017
• Primary Completion: October 19, 2019
• Study Completion: October 19, 2019
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)