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

March 3, 2017 updated by: EvergreenHealth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Washington
  - Kirkland, Washington, United States, 98034
    - EvergreenHealth Heart and Vascular Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiac patients followed at the study site's location.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ECG signal quality Time Frame: 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.	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EvergreenHealth

Investigators

Principal Investigator: Mark Vossler, MD, EvergreenHealth Heart and Vascular Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 13, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CZ2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.