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

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ClinicalTrials.gov Identifier: NCT04241692
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey Moak, Children's National Research Institute

Tracking Information
First Submitted Date  ICMJE January 22, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date July 15, 2020
Estimated Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
  • Difference in Cardiac Arrhythmia Detection Between Recording Systems [ Time Frame: 24 Hours ]
    The presence (yes/no) and frequency of cardiac arrhythmias will be quantitated on each recording system for comparison
  • Difference in Signal Quality Between Recording Systems [ Time Frame: 24 Hours ]
    We will quantitatively evaluate percentage of time signal quality is poor and uninterpretable with each recording system.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2020)
Difference in Skin Discomfort Between Recording Systems [ Time Frame: 24 Hours ]
User will rate skin discomfort on a pre-determined scale: none, mild, moderate, severe at each site of application
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of the Sternal Patch System With a Conventional Holter Recorder
Official Title  ICMJE Comparative Study of the CarnationTM Ambulatory Monitoring Sternal ECG Patch System With a Conventional 24-Hour 7 Lead Holter Monitor Recorder
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
To allow for this type of comparison, each enrolled research subject will wear both systems simultaneously
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Cardiac Arrhythmia
  • Syncope
Intervention  ICMJE
  • Device: CarnationTM Ambulatory Monitoring Sternal ECG Patch System
    A newly developed cardiac rhythm monitoring system
  • Device: Conventional 24-Hour 7 Lead Holter Monitor Recorder
    Traditional recordings made using a standard 24-hour Holter monitor.
Study Arms  ICMJE
  • 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.
    Intervention: Device: CarnationTM Ambulatory Monitoring Sternal ECG Patch 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.
    Intervention: Device: Conventional 24-Hour 7 Lead Holter Monitor Recorder
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 22, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2023
Estimated Primary Completion Date February 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jeffrey Moak, MD 202-4765707 jmoak@childrensnational.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04241692
Other Study ID Numbers  ICMJE Pro00013642
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeffrey Moak, Children's National Research Institute
Study Sponsor  ICMJE Children's National Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Children's National Research Institute
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP