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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 : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Jeffrey Moak, Children's National Research Institute

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrhythmia Syncope Device: CarnationTM Ambulatory Monitoring Sternal ECG Patch System Device: Conventional 24-Hour 7 Lead Holter Monitor Recorder Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Official Title: Comparative Study of the CarnationTM Ambulatory Monitoring Sternal ECG Patch System With a Conventional 24-Hour 7 Lead Holter Monitor Recorder
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

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.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241692


Contacts
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Contact: Jeffrey Moak, MD 202-4765707 jmoak@childrensnational.org

Locations
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United States, District of Columbia
Children's National Hospital
Washington, District of Columbia, United States, 20010
Contact: Jeffrey Moak, MD    202-476-5707    jmoak@childrensnational.org   
Sponsors and Collaborators
Children's National Research Institute
Publications:
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Responsible Party: Jeffrey Moak, Jeffrey P. Moak, MD, Director, Electrophysiology and Pacing; Principle Investigator, Professor of Pediatrics, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT04241692    
Other Study ID Numbers: Pro00013642
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Syncope
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms