NCT02126631

Sternal ECG Patch Comparison Trial

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Bardy Diagnostics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Syncope
• Presyncope
• Palpitations
• Atrial Fibrillation
• Supraventricular Tachycardia

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-04-30
• Last updated: 2014-06-26

Locations

1 site across 1 country: New Zealand