NCT01382953

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Seattle Institute for Cardiac Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-06-27
• Last updated: 2012-01-10

Locations

4 sites across 2 countries: United States, New Zealand