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NCT01559246 · ClinicalTrials.gov registry record
True Continuous ECG Monitoring (TCEM Study)
A clinical trial, sponsored by iRhythm Technologies.
- Completed
- Registry status
- 150
- Enrollment target
NCT01559246: Completed study, sponsored by iRhythm Technologies.
NCT01559246 is a clinical trial that has completed, run by iRhythm Technologies. The registered enrollment target is 150 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01559246 has completed, sponsored by iRhythm Technologies.
- COMPLETED
- Registry status
- 150 participants
- Enrollment target
Study Summary
The purpose of this study is to compare short term (up to 48 hours) traditional cardiac rhythm monitoring using a standard ambulatory Holter monitor versus long term (up to 14 days), continuous ambulatory cardiac rhythm monitoring using a new device cleared by the FDA (Zio® Patch), iRhythm Technologies, Inc., San Francisco CA) in patients with suspected cardiac arrhythmias.
Primary Outcome
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 evide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-12 |
What the finished NCT01559246 record still lists
NCT01559246 is an observational study that tracks outcomes without assigning an intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01559246 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01559246 about?
NCT01559246 is a clinical study titled "True Continuous ECG Monitoring (TCEM Study)". The purpose of this study is to compare short term (up to 48 hours) traditional cardiac rhythm monitoring using a standard ambulatory Holter monitor versus long term (up to 14 days), continuous ambulatory cardiac rhythm monitoring using a new device cleared by the FDA (Zio® Patch), iRhythm Technolog...
What is the current status of trial NCT01559246?
This trial is currently completed. The enrollment target is 150 participants. The study started on 2012-04. Estimated completion is 2012-12.
Who is sponsoring clinical trial NCT01559246?
This trial is sponsored by iRhythm Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
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