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The Simple ECG Monitoring Trial (Comparison of a Novel Recording System With a Standard Holter Monitor)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01382953
First Posted: June 27, 2011
Last Update Posted: January 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cardiac Science Corporation.
Information provided by (Responsible Party):
Seattle Institute for Cardiac Research
  Purpose
The purpose of this research is to simplify the standard recording system of the heart rhythm. The investigators desire to improve the ease of monitoring the cardiac rhythm for 24 hours. The investigators intent is to use a very small, innovative monitoring patch system that relieves the patient of wearing a cumbersome and uncomfortable recording system. This research trial will carry the title "The Simple ECG Monitoring" for Comparison of a Sternal ECG Recording System with a Standard ECG Recording System for Holter Monitoring. The data from the investigational device is for comparative purposes only. It will not be used by medical personnel for study subject treatment or diagnostic purposes.

Condition Intervention
Syncope Pre-syncope Atrial Fibrillation Supraventricular Tachycardia Device: Standard Holter/Investigational patch

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Simple ECG Monitoring Trial (Comparison of a Simple ECG Recording System With a Standard ECG Recording System for Holter Monitoring)

Resource links provided by NLM:


Further study details as provided by Seattle Institute for Cardiac Research:

Primary Outcome Measures:
  • To compare the *diagnostic yield and *ECG signal quality of the standard Holter with that of the Simple ECG Monitoring patch [ Time Frame: 24 Hours ]
    • Diagnostic yield is the proportion of patients for whom an arrhythmogenic source of symptoms is established, or ruled out. The two systems will be correlated following completion of blinded batch reviews.
    • ECG signal quality is scoring the ability of each system to record electrical activity from the atrium (P-waves)using the following scale: Excellent, Good, Fair, Poor, Non-existent.


Secondary Outcome Measures:
  • Skin comfort or discomfort: Was skin irritated? [ Time Frame: 48 Hours ]

    User will rate skin comfort on a pre-determined scale: none, mild, moderate, severe.

    Clinician will examine and rate patient's skin irritation when device is removed, using a pre-determined scale: none, mild, moderate, severe.


  • Device comfort [ Time Frame: 48 Hours ]

    Was device comfortable to wear? User will rate on a pre-determined scale: very uncomfortable, mildly uncomfortable, comfortable.

    Was device inconspicuous under clothing? User will rate on a pre-determined scale: conspicuous, inconspicuous.

    Was ability to sleep affected by wearing the device? User will rate on a pre-determined scale: yes, no.


  • Device stability and contact [ Time Frame: 48 Hours ]
    Did the device stay in place in the chest location where it was attached? Clinician will evaluate visually, and rate on a pre-determined scale: yes, no.

  • User interface [ Time Frame: 48 Hours ]

    Was the patient able to access the button on the device to 'mark' events, such as sensing an episode of palpitations? User will rate on a pre-determined scale: Yes, no.

    Did the clinician find the device easy to attach to patient? Clinician will rate on a pre-determined scale with a rating of 1 through 5: 1 = very easy to attach and 5 = very hard to attach.

    Did the clinician find the device easy to remove from the patient? Clinician will rate on a pre-determined scale with a rating of 1 through 5: 1 = very easy to remove and 5 = very hard to remove.



Enrollment: 50
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Standard Holter/Investigational patch
    The standard Holter and Investigational patch will be worn simultaneously for 24 hours. A single follow-up visit will follow in 2 days to remove both systems which will be sent away for analysis with the results of the standard system used, if pertinent, for patient management.
    Other Names:
    • Cardiac Science Burdick Holter.
    • Investigational patch trilobite system.
Detailed Description:

Externally applied cardiac rhythm monitors are common tools used to diagnose symptoms that may or may not be related to cardiac rhythm abnormalities. Common problems that may lead to the use of cardiac rhythm monitors are syncope (loss of consciousness), near-syncope (near loss of consciousness), palpitations (the sensation of an abnormal heart beat), or monitoring of known cardiac rhythm problems like atrial fibrillation. The purpose of this research is to confirm the clinical value of a much easier-to-use cardiac rhythm monitoring system, hereafter referred to as the Investigational Monitoring System. Prior to discussing the investigational monitoring system, we will review standard electrocardiographic monitoring tools used to evaluate the heart's rhythm.

Excluding a routine 12 lead electrocardiogram that takes a snapshot view of the hearts electrical signal, the most common tool for monitoring the heart rhythm is a Holter monitor. A Holter monitor is also called an ambulatory cardiac monitor. A Holter monitor records every heartbeat for 24 hours. It requires wearing multiple electrodes and carrying a recording system that is usually worn on a belt or on a holster strap. Such systems are relatively bulky and difficult to conceal in public venues. Also, their electrodes often disconnect, especially during sleep when the patient is unaware of electrode detachments that can occur when turning or during exercise. Moreover, they can't be worn during showering. These shortcomings notwithstanding, standard Holters remain the standard of care.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic referral, Cardiology Clinic, Electrophysiology Clinic
Criteria

Inclusion Criteria:

  • Syncope of uncertain etiology or
  • Pre-syncope of uncertain etiology or
  • Palpitations of uncertain etiology or
  • Management of known AF/SVT patients

Exclusion Criteria:

  • Any abnormal or friable skin over the anterior thorax and upper abdomen
  • Sternal incision within 3 months from the date of enrollment
  Contacts and Locations
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): NCT01382953


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Washington
Gene Trobaugh Cardiology
Enumclaw, Washington, United States, 98022
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1001
Christchurch Hospital
Christchurch, New Zealand, 4710
Sponsors and Collaborators
Seattle Institute for Cardiac Research
Cardiac Science Corporation.
Investigators
Principal Investigator: Gust H. Bardy, MD Seattle Institute for Cardiac Research
  More Information

Responsible Party: Seattle Institute for Cardiac Research
ClinicalTrials.gov Identifier: NCT01382953     History of Changes
Other Study ID Numbers: 10131-01B
First Submitted: June 24, 2011
First Posted: June 27, 2011
Last Update Posted: January 10, 2012
Last Verified: January 2012

Keywords provided by Seattle Institute for Cardiac Research:
Holter Monitor, Ambulatory Electrocardiography Monitoring

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