Syncope | Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
Syncope research study
What is the primary objective of this study?
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
Who is eligible to participate?
- Syncope of uncertain etiology or
- Pre-syncope of uncertain etiology or
- Palpitations of uncertain etiology or
- Management of known AF/SVT patients
- 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2016
Completed Date: January 2017
Primary Outcome: ECG signal quality
Secondary Outcome: Device comfort
Study sponsors, principal investigator, and references
Principal Investigator: Mark Kremers, MD
Lead Sponsor: Bardy Diagnostics, Inc.