Atrial Fibrillation Clinical Trial
Official title:
Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
Verified date | March 2017 |
Source | EvergreenHealth |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | EvergreenHealth Heart and Vascular Care | Kirkland | Washington |
Lead Sponsor | Collaborator |
---|---|
EvergreenHealth |
United States,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View 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. — View Citation
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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Skin comfort or discomfort: Was skin irritated? | User will rate skin comfort on pre-determined scale: None, Mild, Moderate, Severe. | 7 days | |
Secondary | Device Comfort | Was device comfortable to wear? User will rate on a predetermined scale: Very Uncomfortable, Mildly Uncomfortable, Comfortable. | 7 days | |
Secondary | 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 | |
Secondary | Diagnostic Yield | Diagnostic Yield: proportion of patients for whom an arrhythmogenic source of symptoms is established or eliminated as a diagnosis. | 7 days |
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