Clinical trial NCT02952781: Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
Official title: Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syncope
Presyncope
Atrial Fibrillation
Supraventricular Tachycardia
Keywords: ECG Monitoring
Palpitations
Lead sponsor: EvergreenHealth
Sponsor class: OTHER
First posted: 2016-11-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac patients followed at the study site's location.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: ECG signal quality
timeFrame: 7 days
Secondary outcomes:
measure: Skin comfort or discomfort: Was skin irritated?
timeFrame: 7 days
measure: Device Comfort
timeFrame: 7 days
measure: Device Stability and Contact
timeFrame: 7 days
measure: Diagnostic Yield
timeFrame: 7 days
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: EvergreenHealth Heart and Vascular Care
state: Washington
Study officials:
affiliation: Evergreenhealth Heart and Vascular Care
name: Mark Vossler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Clark PI, Glasser SP, Spoto E Jr. Arrhythmias detected by ambulatory monitoring. Lack of correlation with symptoms of dizziness and syncope. Chest. 1980 Jun;77(6):722-5. doi: 10.1378/chest.77.6.722.
citation: Cumbee SR, Pryor RE, Linzer M. Cardiac loop ECG recording: a new noninvasive diagnostic test in recurrent syncope. South Med J. 1990 Jan;83(1):39-43. doi: 10.1097/00007611-199001000-00013.