Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial|
- ECG signal quality [ Time Frame: 14 days ] [ Designated as safety issue: No ]ECG signal quality = scoring the ability of each system to record electrical activity from the atrium (P-waves). The Physician Event Committee will independently score the P-waves from all recordings, using the following scale: Excellent, Good, Fair, Poor, Non-existent.
- Device comfort [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]Secondary outcome measures will include Human Factors performance of the 2 systems, which will be scored and compared in the following areas and duration of patch adherence: skin irritation, comfort, contact and stability.
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
The purpose of this research is to confirm the clinical value of a new P-wave sensitive recording vector combined with an easy-to-use long-term cardiac rhythm monitoring patch system, the CarnationTM Ambulatory Monitoring (CAM) System. The P-wave is a critical aspect of the electrocardiogram and a key finding for proper arrhythmia diagnosis. The CAM system is optimized for both ease of use and for maximum P-wave clarity for arrhythmia diagnosis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02031484
|United States, Illinois|
|University of Chicago||Not yet recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Martin Burke, MD 773-702-5988 firstname.lastname@example.org|
|Principal Investigator: Martin Burke, MD|
|United States, Iowa|
|University of Iowa||Not yet recruiting|
|Iowa City, Iowa, United States, 52240|
|Contact: Brian Olshansky, MD 319-331-0342 email@example.com|
|Principal Investigator: Brian Olshansky, MD|
|United States, North Carolina|
|Mid Carolina Cardiology||Not yet recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Mark Kremers, MD 704-343-9800 firstname.lastname@example.org|
|Principal Investigator: Mark Kremers, MD|
|United States, Washington|
|Eastside Cardiology||Not yet recruiting|
|Kirkland, Washington, United States, 98034|
|Contact: Mark Vossler, MD 425-899-0555 email@example.com|
|Principal Investigator: Mark Vossler, MD|
|Principal Investigator:||Mark Kremers, MD||Mid Carolina Cardiology|