Sternal ECG Patch Comparison Trial

Comparison of a Sternal ECG Patch With a Standard Recording System for Holter Monitoring

This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system. Holters represent the current standard for continuous recording of the ECG over extended periods.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Syncope; Supraventricular Tachycardia; Presyncope; Palpitations

Detailed Description

The purpose of this research is to simplify the system of recording ECGs. Carnation Ambulatory Monitoring (CAM) System is a small patch system that can be worn during most activities include showering. Each patient will be his or her own control, and will wear the CAM and Holter systems simultaneously for 24 hours. Both systems will then be sent out for analysis.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 1142
    • Auckland City Hospital
    • Contact: Warren Smith, MBChB; Phone Number: +64 (021) 774 140; Email: WarrenS@adhb.govt.nz
    • Principal Investigator: Warren Smith, MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cardiac patients at Auckland City Hospital, Auckland, New Zealand

Description

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

Study Plan

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	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. Diagnostic yield will also be assessed.	24 hours of patient use, plus shipping and analysis time ~ 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device comfort	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.	24 hours

Collaborators and Investigators

• Sponsor: Bardy Diagnostics, Inc.
• Investigators: Study Director: Jon Hunt, PhD, Bardy Diagnostics, Inc. (sponsor); Principal Investigator: Warren Smith, MBChB, Auckland City Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: April 28, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (Estimate): April 30, 2014

Study Record Updates

• Last Update Posted (Estimate): June 26, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Unconsciousness; Consciousness Disorders; Atrial Fibrillation; Tachycardia; Syncope; Tachycardia, Supraventricular
• Other Study ID Numbers: 6147 (Other Identifier: University of Colorado CTRC)