Sternal ECG Patch Comparison Trial

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

• Registration Number: NCT02126631
• Lead Sponsor: Bardy Diagnostics, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26
• Study Start: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07

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	24 hours of patient use, plus shipping and analysis time ~ 2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Device comfort	24 hours	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 (1)

Auckland City Hospital; 🇳🇿 Auckland, New Zealand