Comparative Study of the Sternal Patch System With a Conventional Holter Recorder

NCT04241692 | Unknown FDA Device

• 1 other identifier: Pro00013642
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a comparison of two externally worn recording systems for documentation of cardiac arrhythmias in symptomatic patients or patients at risk for arrhythmia. Non-invasive documentation of cardiac arrhythmias can be done using the standard electrocardiogram (ECG). This has limitations given it is performed for only a 10 sec period. Alternative methods for making longer term recording have been developed. The standard device is the 24 hour 7-lead Holter monitor. Newer technology has simplified the hardware needed to make these longer term recordings, and incorporate a self-contained recording system in a patch that is applied over the patient's chest. Little is known comparing the sensitivity, specificity and recording noise / signal artifact between the older technology (standard 24-Hour Holter monitor) and the Patch electrode.

Conditions

Cardiac Arrhythmia; Syncope

Outcome Measures

Primary Outcomes (2)

• Difference in Cardiac Arrhythmia Detection Between Recording Systems

  The presence (yes/no) and frequency of cardiac arrhythmias will be quantitated on each recording system for comparison

  24 Hours

• Difference in Signal Quality Between Recording Systems

  We will quantitatively evaluate percentage of time signal quality is poor and uninterpretable with each recording system.

  24 Hours

Secondary Outcomes (1)

• Difference in Skin Discomfort Between Recording Systems

  24 Hours

Study Arms (2)

Application of Carnation Ambulatory Patch Monitoring System

EXPERIMENTAL

The patient will wear a Standard Holter Monitor and the CAM Patch system simultaneously for 24 hours.

Device: CarnationTM Ambulatory Monitoring Sternal ECG Patch System

Application Conventional 24-Hour Holter Monitor Recorder

EXPERIMENTAL

The patient will wear a Standard Holter Monitor and the CAM Patch system simultaneously for 24 hours.

Device: Conventional 24-Hour 7 Lead Holter Monitor Recorder

Interventions

CarnationTM Ambulatory Monitoring Sternal ECG Patch System DEVICE

A newly developed cardiac rhythm monitoring system

Application of Carnation Ambulatory Patch Monitoring System

Conventional 24-Hour 7 Lead Holter Monitor Recorder DEVICE

Traditional recordings made using a standard 24-hour Holter monitor.

Application Conventional 24-Hour Holter Monitor Recorder

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Any infant, child, adolescent, or young adult with one or more of the following:
• Syncope
• Pre-syncope
• Palpitations
• Management of a known or suspected cardiac arrhythmia

You may not qualify if:

• Any inflamed or friable skin over the anterior thorax and upper abdomen or a sternal incision within 3 months from the date of enrollment

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (7)

• Bigger JT Jr, Reiffel JA, Coromilas J. Ambulatory electrocardiography. In: Platia E, ed. Non-Pharmacologic Management of Cardiac Arrhythmias. Philadelphia: JB Lippincott, 1986:36-61.

  BACKGROUND

• Clark PI, Glasser SP, Spoto E Jr. Arrhythmias detected by ambulatory monitoring. Lack of correlation with symptoms of dizziness and syncope. Chest. 1980 Jun;77(6):722-5. doi: 10.1378/chest.77.6.722.

  PMID: 7398383 BACKGROUND

• Gibson TC, Heitzman MR. Diagnostic efficacy of 24-hour electrocardiographic monitoring for syncope. Am J Cardiol. 1984 Apr 1;53(8):1013-7. doi: 10.1016/0002-9149(84)90628-3.

  PMID: 6702676 BACKGROUND

• Heilbron EL. Advances in modern electrocardiographic equipment for long-term ambulatory monitoring. Card Electrophysiol Rev. 2002 Sep;6(3):185-9. doi: 10.1023/a:1016322218490.

  PMID: 12114836 BACKGROUND

• Jonas S, Klein I, Dimant J. Importance of Holter monitoring in patients with periodic cerebral symptoms. Ann Neurol. 1977 May;1(5):470-4. doi: 10.1002/ana.410010511.

  PMID: 363045 BACKGROUND

• Kapoor WN, Cha R, Peterson JR, Wieand HS, Karpf M. Prolonged electrocardiographic monitoring in patients with syncope. Importance of frequent or repetitive ventricular ectopy. Am J Med. 1987 Jan;82(1):20-8. doi: 10.1016/0002-9343(87)90372-x.

  PMID: 2432783 BACKGROUND

• Zimetbaum P, Josephson ME. Evaluation of patients with palpitations. N Engl J Med. 1998 May 7;338(19):1369-73. doi: 10.1056/NEJM199805073381907. No abstract available.

  PMID: 9571258 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Syncope

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeffrey P. Moak, MD, Director, Electrophysiology and Pacing; Principle Investigator, Professor of Pediatrics

Model Details: To allow for this type of comparison, each enrolled research subject will wear both systems simultaneously

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: November 19, 2020
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)