The purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM system improves arrhythmia diagnosis.
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. The primary endpoint for this comparison will be diagnostic yield with secondary endpoints being ease of use and comfort.
Study Type
OBSERVATIONAL
Enrollment
30
Each patient will be provided with both a Zio-XT Patch monitoring system and the CAM system and will be instructed to wear both simultaneously for 7 days.
EvergreenHealth Heart and Vascular Care
Kirkland, Washington, United States
ECG signal quality
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.
Time frame: 7 days
Skin comfort or discomfort: Was skin irritated?
User will rate skin comfort on pre-determined scale: None, Mild, Moderate, Severe.
Time frame: 7 days
Device Comfort
Was device comfortable to wear? User will rate on a predetermined scale: Very Uncomfortable, Mildly Uncomfortable, Comfortable.
Time frame: 7 days
Device Stability and Contact
Did the device stay in place in the chest location where it was attached for the time period indicated? Clinician will evaluate visually, and rate on a predetermined scale: Yes, No.
Time frame: 7 days
Diagnostic Yield
Diagnostic Yield: proportion of patients for whom an arrhythmogenic source of symptoms is established or eliminated as a diagnosis.
Time frame: 7 days
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