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