The Simple ECG Monitoring Trial (Comparison of a Novel Recording System With a Standard Holter Monitor)
NCT01382953 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2012-01-10
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
Interventions
- 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.
Sponsors & Collaborators
-
Cardiac Science Corporation.
collaborator UNKNOWN -
Seattle Institute for Cardiac Research
lead OTHER
Principal Investigators
-
Gust H. Bardy, MD · Seattle Institute for Cardiac Research
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2011-10-31
- Completion
- 2011-10-31
Countries
- United States
- New Zealand
Study Locations
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