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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Bardy Diagnostics, Inc.
Sponsor:
Information provided by (Responsible Party):
Bardy Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT02031484
First received: January 8, 2014
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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
Syncope
Presyncope
Palpitations
Atrial Fibrillation
Supraventricular Tachycardia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial

Resource links provided by NLM:


Further study details as provided by Bardy Diagnostics, Inc.:

Primary Outcome Measures:
  • ECG signal quality [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    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:
  • Device comfort [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: July 2014
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031484

Locations
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Martin Burke, MD    773-702-5988    mburke@medicine.bsd.uchicago.edu   
Principal Investigator: Martin Burke, MD         
United States, Iowa
University of Iowa Not yet recruiting
Iowa City, Iowa, United States, 52240
Contact: Brian Olshansky, MD    319-331-0342    brian-olshansky@uiowa.edu   
Principal Investigator: Brian Olshansky, MD         
United States, North Carolina
Mid Carolina Cardiology Not yet recruiting
Charlotte, North Carolina, United States, 28204
Contact: Mark Kremers, MD    704-343-9800    mskremers@novanthealth.org   
Principal Investigator: Mark Kremers, MD         
United States, Washington
Eastside Cardiology Not yet recruiting
Kirkland, Washington, United States, 98034
Contact: Mark Vossler, MD    425-899-0555    vosslerm1@mac.com   
Principal Investigator: Mark Vossler, MD         
Sponsors and Collaborators
Bardy Diagnostics, Inc.
Investigators
Principal Investigator: Mark Kremers, MD Mid Carolina Cardiology
  More Information

No publications provided

Responsible Party: Bardy Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT02031484     History of Changes
Other Study ID Numbers: Zio study
Study First Received: January 8, 2014
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 20, 2014