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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 extended periods.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Syncope

Presyncope

Palpitations

Atrial Fibrillation

Supraventricular Tachycardia

Study Interventions

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.

Study Arms

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.

Study Status

Enrolling by invitation

Start Date: July 2016

Completed Date: January 2017

Phase:

Type: Observational

Design:

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.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02031484

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