Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial

Conditions
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Syncope, Presyncope, Atrial Fibrillation, Supraventricular Tachycardia

Intervention / Treatment
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* Device: EKG Patch monitors (Zio and Carnation)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EKG Patch monitors (Zio and Carnation)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin comfort or discomfort: Was skin irritated? | User will rate skin comfort on pre-determined scale: None, Mild, Moderate, Severe. | 7 days | 
| Device Comfort | Was device comfortable to wear? User will rate on a predetermined scale: Very Uncomfortable, Mildly Uncomfortable, Comfortable. | 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. | 7 days | 
| Diagnostic Yield | Diagnostic Yield: proportion of patients for whom an arrhythmogenic source of symptoms is established or eliminated as a diagnosis. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECG Monitoring, Palpitations