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

EvergreenHealth

Status: Completed

Conditions: Atrial Fibrillation; Syncope; Supraventricular Tachycardia; Presyncope

Treatments: Device: EKG Patch monitors (Zio and Carnation)

Study type: Observational

Funder types: Other

Identifiers

NCT02952781

CZ2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female

• Written informed consent

• Patients with one or more of the following:

  • 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.
• Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing