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

Completed

• Conditions: Presyncope; Syncope; Atrial Fibrillation; Supraventricular Tachycardia

• Registration Number: NCT02952781
• Lead Sponsor: EvergreenHealth

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.

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-31
• Study First Posted: 2016-11-02
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-03
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

EvergreenHealth Heart and Vascular Care; 🇺🇸 Kirkland, Washington, United States