NCT02031484

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

• 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 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.

Conditions

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

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2014-01-09
• Last updated: 2016-10-07

Locations

4 sites across 1 country: United States