Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
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.
Inclusion Criteria:

 -  Male or female

 -  Written informed consent

 -  Patients with one or more of the following:

 -  Syncope of uncertain etiology; or

 -  Pre-syncope of uncertain etiology; or

 -  Palpitations of uncertain etiology; or

 -  Management of known AF/SVT patients

 Exclusion Criteria:

 -  Any dermatitis or infected skin over the sternum (Carnation patch) or left upper
 anterior thorax (Zio patch).

 -  A sternal or thoracic incision that extends under the patch within 3 months from the
 date of enrollment.

 -  Cognitive deficits that would interfere with the subject's ability to give informed
 consent or perform study testing