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

NCT01382953 | Completed DMC

• 1 other identifier: 10131-01B
• Study Type: observational
• Target: 50
• Locations: 2 countries
• Sites: 4

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.

Conditions

Syncope; Pre-syncope; Atrial Fibrillation; Supraventricular Tachycardia

Keywords

Holter Monitor, Ambulatory Electrocardiography Monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Skin comfort or discomfort: Was skin irritated?

  48 Hours

• Device comfort

  48 Hours

• Device stability and contact

  48 Hours

• User interface

  48 Hours

Interventions

Standard Holter/Investigational patch DEVICE

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.

Also known as: Cardiac Science Burdick Holter., Investigational patch trilobite system.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinic referral, Cardiology Clinic, Electrophysiology Clinic

You may qualify if:

• Syncope of uncertain etiology or
• Pre-syncope of uncertain etiology or
• Palpitations of uncertain etiology or
• Management of known AF/SVT patients

You may not qualify if:

• Any abnormal or friable skin over the anterior thorax and upper abdomen
• Sternal incision within 3 months from the date of enrollment

Sponsors & Collaborators

• Seattle Institute for Cardiac Research: lead
• Cardiac Science Corporation.: collaborator

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Gene Trobaugh Cardiology

Enumclaw, Washington, 98022, United States

Location

Auckland City Hospital

Auckland, 1001, New Zealand

Location

Christchurch Hospital

Christchurch, 4710, New Zealand

Location

MeSH Terms

Conditions

Syncope; Atrial Fibrillation; Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Gust H. Bardy, MD

  Seattle Institute for Cardiac Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 27, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 10, 2012

Record last verified: 2012-01

Locations

US (2); NZ (2)