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

Bardy Diagnostics

Status: Unknown

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02031484

Zio study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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