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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02031484
Recruitment Status : Enrolling by invitation
First Posted : January 9, 2014
Last Update Posted : October 7, 2016
Information provided by (Responsible Party):
Bardy Diagnostics, Inc.

Brief Summary:
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.

Condition or disease
Syncope Presyncope Palpitations Atrial Fibrillation Supraventricular Tachycardia

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
Study Start Date : July 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. ECG signal quality [ Time Frame: 14 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, using the following scale: Excellent, Good, Fair, Poor, Non-existent.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in Chicago, Charlotte, and Iowa under the care of a physician for symptoms listed in the inclusion criteria

Inclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02031484

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52240
United States, North Carolina
Mid Carolina Cardiology
Charlotte, North Carolina, United States, 28204
United States, Washington
Eastside Cardiology
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Bardy Diagnostics, Inc.
Principal Investigator: Mark Kremers, MD Mid Carolina Cardiology

Responsible Party: Bardy Diagnostics, Inc. Identifier: NCT02031484     History of Changes
Other Study ID Numbers: Zio study
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: October 7, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Tachycardia, Supraventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms