True Continuous ECG Monitoring (TCEM Study) (TCEM)
|ClinicalTrials.gov Identifier: NCT01559246|
Recruitment Status : Unknown
Verified November 2012 by iRhythm Technologies, Inc..
Recruitment status was: Active, not recruiting
First Posted : March 21, 2012
Last Update Posted : November 7, 2012
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Observational Model:||Case Control|
|Official Title:||Comparison of Short Term Holter Monitoring vs. Long Term Zio(R)Patch True Continuous ECG Monitoring (TCEM Study)|
|Study Start Date :||April 2012|
|Estimated Primary Completion Date :||November 2012|
|Estimated Study Completion Date :||December 2012|
Subjects 18 years of age or greater that have indications for traditional cardiac(Holter) monitoring.
- Arrhythmia detection for Zio® patch and the traditional ambulatory Holter monitor. [ Time Frame: Up to 14 days. ]Data will be examined to determine the difference in the number of 6 types of arrhythmias detected at maximum observation times of 14 days and 24 hours respectively. In comparing the difference of the number of arrhythmias for the Zio® Patch and the Holter data, we are expecting a skewed distribution of the differences and will use a paired Wilcoxon Signed Rank Test since the normality assumption is not met for a paired t-test. If the difference is significantly greater than zero, there is evidence that the Zio® Patch is an improvement in this sample.
- Subjects ease in comfort for the Zio® Patch and the traditional ambulatory Holter monitor. [ Time Frame: Up to14 days. ]Subjects will be given surveys to complete at different time points. Surveys to include questions assessing subjects preference in devices. McNemar's Test will be used to examine if the responses for ease of wear was different between the Zio® Patch and the Holter. Comparing both devices when the Holter is returned in the first 24/48 hours, and comparing the Holter at 24/48 hours and the Zio® Patch at total observation (up to 14 days). McNemar's Test will be used to compare if the patient would use the Zio® Patch again and if they would use the Holter.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559246
|United States, California|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Eric Topol, MD||Scripps Translational Science Institute|