NCT02952781

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: EvergreenHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM system improves arrhythmia diagnosis.

Detailed description

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. The primary endpoint for this comparison will be diagnostic yield with secondary endpoints being ease of use and comfort.

Conditions

• Syncope
• Presyncope
• Atrial Fibrillation
• Supraventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	EKG Patch monitors (Zio and Carnation)	Each patient will be provided with both a Zio-XT Patch monitoring system and the CAM system and will be instructed to wear both simultaneously for 7 days.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2016-11-02
• Last updated: 2017-03-07

Locations

1 site across 1 country: United States