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

Sponsor

EvergreenHealth (Other)

Overall Status

Completed

CT.gov ID

NCT02952781

Collaborator

(none)

Enrollment

Location

Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Syncope Presyncope Atrial Fibrillation Supraventricular Tachycardia	Device: EKG Patch monitors (Zio and Carnation)

Detailed Description

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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Outcome Measures

Primary Outcome Measures

ECG signal quality [7 days]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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