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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| ECG signal quality | 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Device comfort | 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. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients in Chicago, Charlotte, and Iowa under the care of a physician for symptoms listed in the inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mark Kremers, MD | Mid Carolina Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States | ||
| University of Iowa |
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| ID | Term |
|---|---|
| D013575 | Syncope |
| D001281 | Atrial Fibrillation |
| D013617 | Tachycardia, Supraventricular |
| ID | Term |
|---|---|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| Iowa City |
| Iowa |
| 52240 |
| United States |
| Mid Carolina Cardiology | Charlotte | North Carolina | 28204 | United States |
| Eastside Cardiology | Kirkland | Washington | 98034 | United States |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |