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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02031484

Enrollment

Registered

2014-01-09

Start date

2016-07-31

Completion date

2017-01-31

Last updated

2016-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Palpitations, Presyncope, Supraventricular Tachycardia, Syncope

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
ECG signal quality	14 days	ECG signal quality = scoring the ability of each system to record electrical activity from the atrium (P-waves). The Physician Event Committee will independently score the P-waves from all recordings, using the following scale: Excellent, Good, Fair, Poor, Non-existent.

Secondary

Measure	Time frame	Description
Device comfort	14 days	Secondary outcome measures will include Human Factors performance of the 2 systems, which will be scored and compared in the following areas and duration of patch adherence: skin irritation, comfort, contact and stability.

Countries

United States

Outcome results