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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Skin comfort or discomfort: Was skin irritated? | User will rate skin comfort on pre-determined scale: None, Mild, Moderate, Severe. | 7 days |
| Device Comfort | Was device comfortable to wear? User will rate on a predetermined scale: Very Uncomfortable, Mildly Uncomfortable, Comfortable. |
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Inclusion Criteria:
Male or female
Written informed consent
Patients with one or more of the following:
Exclusion Criteria:
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Cardiac patients followed at the study site's location.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Vossler, MD | Evergreenhealth Heart and Vascular Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EvergreenHealth Heart and Vascular Care | Kirkland | Washington | 98034 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2331188 | Result | Bass EB, Curtiss EI, Arena VC, Hanusa BH, Cecchetti A, Karpf M, Kapoor WN. The duration of Holter monitoring in patients with syncope. Is 24 hours enough? Arch Intern Med. 1990 May;150(5):1073-8. | |
| 10902039 | Result | Clinical value of vectorcardiography, Holter monitoring and quantitative electrocardiology. Belgian Society of Cardiology. Working Group on Electrocardiology, Exercise Testing and Cardiac Rehabilitation. Acta Cardiol. 2000 Jun;55(3):157-62. doi: 10.2143/AC.55.3.2005733. |
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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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| 7 days |
| Device Stability and Contact | 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. | 7 days |
| Diagnostic Yield | Diagnostic Yield: proportion of patients for whom an arrhythmogenic source of symptoms is established or eliminated as a diagnosis. | 7 days |
| 10676584 | Result | Bell C, Kapral M. Use of ambulatory electrocardiography for the detection of paroxysmal atrial fibrillation in patients with stroke. Canadian Task Force on Preventive Health Care. Can J Neurol Sci. 2000 Feb;27(1):25-31. doi: 10.1017/s0317167100051933. |
| 3663425 | Result | Brown AP, Dawkins KD, Davies JG. Detection of arrhythmias: use of a patient-activated ambulatory electrocardiogram device with a solid-state memory loop. Br Heart J. 1987 Sep;58(3):251-3. doi: 10.1136/hrt.58.3.251. |
| 8238063 | Result | Calkins H, Byrne M, el-Atassi R, Kalbfleisch S, Langberg JJ, Morady F. The economic burden of unrecognized vasodepressor syncope. Am J Med. 1993 Nov;95(5):473-9. doi: 10.1016/0002-9343(93)90329-n. |
| 7398383 | Result | 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. |
| 2300833 | Result | 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. |
| 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 |