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

Comparative Study of the CarnationTM Ambulatory Monitoring Sternal ECG Patch System With a Conventional 24-Hour 7 Lead Holter Monitor Recorder

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Syncope; Cardiac Arrhythmia
• Intervention / Treatment: Device: CarnationTM Ambulatory Monitoring Sternal ECG Patch System; Device: Conventional 24-Hour 7 Lead Holter Monitor Recorder

Detailed Description

Objective: 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 by attempting to take a snapshot view of a patient's cardiac rhythm using the standard electrocardiogram (ECG). This has limitations given it is performed for only a 10 sec period, and requires the patient to be symptomatic at the time of the recording. Therefore, the sensitivity of this technique is very low. Alternative methods for making longer term recording have been developed and used for decades. The standard device is the 24 hour 7-lead Holter monitor. These devises are large, restrict patient mobility and require cables to be connected between the applied skin ECG electrodes placed on the patient's chest and the recording device. 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. These units allow for unlimited mobility, are significantly smaller, easier to wear and have eliminated the requirement for cables to connect the electrodes with the recording device. However, 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.

Specific Aims:

Aim 1: Comparison of Cardiac Arrhythmia Documentation between Standard 24-Hour Holter Monitor vs. Patch Monitor To evaluate the diagnostic yield for cardiac arrhythmias between the two recording systems.

The presence and frequency (qualitative and quantitative) of cardiac arrhythmias documented by each recording system with be compared. To allow for this type of comparison, each enrolled research subject with wear both systems simultaneously.

Aim 2: Comparison of Recording Quality between Standard 24-Hour Holter Monitor vs. Patch Monitor To evaluate percentage of time ECG signal quality is poor and uninterpretable.

Aim 3: Comparison of Comfortability Between Standard 24-HourHolter Monitor vs. Patch Monitor Recording Quality To evaluate level of patient's discomfort during the application of each recording system. Since both systems will be applied at the same time it may be hard for the research subject to rank the comfortability of the two systems. We will focus in this aim at more objective measures such as skin irritation under the recording electrodes, and frequency of time during which the skin electrodes come off the patient and require re-application.

Hypotheses:

Aim 1: Comparison of Cardiac Arrhythmia Documentation between Standard 24-Hour Holter Monitor vs. Patch Monitor We hypothesize that there will be no qualitative or quantitative difference in arrhythmia frequency between the two recording techniques, i.e. that both devices will detect all spontaneous arrhythmias with similar quantitative counts of ectopic beats (+/- 5%).

Aim 2: Comparison of Recording Quality between Standard 24-Hour Holter Monitor vs. Patch Monitor We hypothesize that recording quality will be better with the Patch Monitor since there are not 7 separately applied skin electrodes and cables connecting the electrodes with the recorder, resulting in a lower percent of poor ECG signal quality.

Aim 3: Comparison of Comfortability Between Standard 24-hour Holter Monitor vs. Patch Monitor Recording Quality We hypothesize that the degree of skin irritation and level of discomfort in the region of application will be less with the Patch Monitor. We hypothesize that the ECG leads will fall off from its site of application will be less with the Patch Monitor.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any infant, child, adolescent, or young adult with one or more of the following:

  1. Syncope
  2. Pre-syncope
  3. Palpitations
  4. Management of a known or suspected cardiac arrhythmia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application of Carnation Ambulatory Patch Monitoring System; 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; A newly developed cardiac rhythm monitoring system
Experimental: Application Conventional 24-Hour Holter Monitor Recorder; 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; Traditional recordings made using a standard 24-hour Holter monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Skin Discomfort Between Recording Systems	User will rate skin discomfort on a pre-determined scale: none, mild, moderate, severe at each site of application	24 Hours

Collaborators and Investigators

• Sponsor: Children's National Research Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2020
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Arrhythmias, Cardiac; Syncope
• Other Study ID Numbers: Pro00013642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes