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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382953
• Other study ID #: 10131-01B
• Status: Completed
• Phase: N/A
• First received: June 24, 2011
• Last updated: January 7, 2012
• Start date: August 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2012
• Source: Seattle Institute for Cardiac Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Pre-syncope
• Supraventricular Tachycardia
• Syncope
• Tachycardia
• Tachycardia, Supraventricular

Intervention

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.

Locations

Country	Name	City	State
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
United States	University of Chicago	Chicago	Illinois
United States	Gene Trobaugh Cardiology	Enumclaw	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Institute for Cardiac Research	Cardiac Science Corporation.

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the *diagnostic yield and *ECG signal quality of the standard Holter with that of the Simple ECG Monitoring patch	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.	24 Hours	Yes
Secondary	Skin comfort or discomfort: Was skin irritated?	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.	48 Hours	Yes
Secondary	Device comfort	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.	48 Hours	No
Secondary	Device stability and contact	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.	48 Hours	Yes
Secondary	User interface	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.	48 Hours	No