Clinical trial NCT01382953: The Simple ECG Monitoring Trial (Comparison of a Novel Recording System With a Standard Holter Monitor)
Official title: The Simple ECG Monitoring Trial (Comparison of a Simple ECG Recording System With a Standard ECG Recording System for Holter Monitoring)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Pre-syncope
Atrial Fibrillation
Supraventricular Tachycardia
Keywords: Holter Monitor, Ambulatory Electrocardiography Monitoring
Lead sponsor: Seattle Institute for Cardiac Research
Sponsor class: OTHER
Collaborators: name: Cardiac Science Corporation.
First posted: 2011-06-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic referral, Cardiology Clinic, Electrophysiology Clinic

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.

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 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

Primary outcomes:
measure: To compare the *diagnostic yield and *ECG signal quality of the standard Holter with that of the Simple ECG Monitoring patch
timeFrame: 24 Hours
Secondary outcomes:
measure: Skin comfort or discomfort: Was skin irritated?
timeFrame: 48 Hours
measure: Device comfort
timeFrame: 48 Hours
measure: Device stability and contact
timeFrame: 48 Hours
measure: User interface
timeFrame: 48 Hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Enumclaw
country: United States
facility: Gene Trobaugh Cardiology
state: Washington
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
Study officials:
affiliation: Seattle Institute for Cardiac Research
name: Gust H. Bardy, MD
role: PRINCIPAL_INVESTIGATOR
References: