Atrial Fibrillation, Presyncope, Supraventricular Tachycardia, Syncope
Conditions
Keywords
ECG Monitoring, Palpitations
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.
Interventions
DEVICEEKG Patch monitors (Zio and Carnation)
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.
Sponsors
EvergreenHealth
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECG signal quality | 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
| Measure | Time frame | Description |
|---|---|---|
| Skin comfort or discomfort: Was skin irritated? | 7 days | User will rate skin comfort on pre-determined scale: None, Mild, Moderate, Severe. |
| Device Comfort | 7 days | Was device comfortable to wear? User will rate on a predetermined scale: Very Uncomfortable, Mildly Uncomfortable, Comfortable. |
| Device Stability and Contact | 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. |
| Diagnostic Yield | 7 days | Diagnostic Yield: proportion of patients for whom an arrhythmogenic source of symptoms is established or eliminated as a diagnosis. |
Countries
United States
Outcome results
None listed