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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01382953
Registration number
NCT01382953
Ethics application status
Date submitted
24/06/2011
Date registered
27/06/2011
Date last updated
10/01/2012
Titles & IDs
Public title
The Simple ECG Monitoring Trial (Comparison of a Novel Recording System With a Standard Holter Monitor)
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Scientific title
The Simple ECG Monitoring Trial (Comparison of a Simple ECG Recording System With a Standard ECG Recording System for Holter Monitoring)
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Secondary ID [1]
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10131-01B
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Syncope
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Pre-syncope
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Atrial Fibrillation
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Supraventricular Tachycardia
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Standard Holter/Investigational patch
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To compare the *diagnostic yield and *ECG signal quality of the standard Holter with that of the Simple ECG Monitoring patch
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Assessment method [1]
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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.
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Timepoint [1]
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24 Hours
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Secondary outcome [1]
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Skin comfort or discomfort: Was skin irritated?
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Assessment method [1]
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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.
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Timepoint [1]
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48 Hours
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Secondary outcome [2]
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Device comfort
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Assessment method [2]
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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.
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Timepoint [2]
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48 Hours
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Secondary outcome [3]
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Device stability and contact
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Assessment method [3]
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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.
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Timepoint [3]
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48 Hours
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Secondary outcome [4]
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User interface
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Assessment method [4]
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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.
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Timepoint [4]
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48 Hours
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Eligibility
Key inclusion criteria
- Syncope of uncertain etiology or
- Pre-syncope of uncertain etiology or
- Palpitations of uncertain etiology or
- Management of known AF/SVT patients
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any abnormal or friable skin over the anterior thorax and upper abdomen
- Sternal incision within 3 months from the date of enrollment
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2011
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Illinois
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Country [2]
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United States of America
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State/province [2]
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Washington
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Country [3]
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New Zealand
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State/province [3]
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Auckland
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Country [4]
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New Zealand
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State/province [4]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
Seattle Institute for Cardiac Research
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Cardiac Science Corporation.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01382953
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gust H. Bardy, MD
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Address
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Seattle Institute for Cardiac Research
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01382953
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