Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
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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.
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.
Secondary Outcome Measures
Device comfort [ Time Frame: 14 days ]
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients in Chicago, Charlotte, and Iowa under the care of a physician for symptoms listed in the inclusion criteria
Syncope of uncertain etiology or
Pre-syncope of uncertain etiology or
Palpitations of uncertain etiology or
Management of known AF/SVT patients
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