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OpenTrials
Completed

NCT Number: NCT02952781

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

The purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM system improves arrhythmia diagnosis.

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Key information

Conditions

Syncope Arrhythmias, Cardiac Atrial Fibrillation Cardiac Conduction System Disease Cardiovascular Diseases Consciousness Disorders Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Presyncope Signs and Symptoms Supraventricular Tachycardia Tachycardia Tachycardia, Supraventricular Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

EvergreenHealth Heart and Vascular Care

Kirkland, Washington, 98034, United States

About 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. The primary endpoint for this comparison will be diagnostic yield with secondary endpoints being ease of use and comfort.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Written informed consent
  • Patients with one or more of the following:
  • 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.
  • Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing

Treatment and study plan

EKG Patch monitors (Zio and Carnation)

Device

Each patient will be provided with both a Zio-XT Patch monitoring system and the CAM system and will be instructed to wear both simultaneously for 7 days.

Primary outcomes

  1. ECG signal quality

    Time frame: 7 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.

Secondary outcomes

  1. Skin comfort or discomfort: Was skin irritated?

    Time frame: 7 days

    User will rate skin comfort on pre-determined scale: None, Mild, Moderate, Severe.

  2. Device Comfort

    Time frame: 7 days

    Was device comfortable to wear? User will rate on a predetermined scale: Very Uncomfortable, Mildly Uncomfortable, Comfortable.

  3. Device Stability and Contact

    Time frame: 7 days

    Did the device stay in place in the chest location where it was attached for the time period indicated? Clinician will evaluate visually, and rate on a predetermined scale: Yes, No.

  4. Diagnostic Yield

    Time frame: 7 days

    Diagnostic Yield: proportion of patients for whom an arrhythmogenic source of symptoms is established or eliminated as a diagnosis.

Sponsors and collaborators

Lead sponsor

EvergreenHealth

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2016
Registry last updated
Mar 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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