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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Syncope Presyncope Palpitations Atrial Fibrillation Supraventricular Tachycardia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No