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

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

• Registration Number: NCT02031484
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Study Start: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-05
• Last Update Posted: 2016-10-07
• Primary Completion: 2016-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ECG signal quality	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

Name	Time	Method
Device comfort	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.

Trial Locations

Locations (4)

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Eastside Cardiology; 🇺🇸 Kirkland, Washington, United States

Mid Carolina Cardiology; 🇺🇸 Charlotte, North Carolina, United States