Atrial Fibrillation Clinical Trial
Official title:
Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
Verified date | October 2016 |
Source | Bardy Diagnostics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Mid Carolina Cardiology | Charlotte | North Carolina |
United States | University of Chicago | Chicago | Illinois |
United States | University of Iowa | Iowa City | Iowa |
United States | Eastside Cardiology | Kirkland | Washington |
Lead Sponsor | Collaborator |
---|---|
Bardy Diagnostics, Inc. |
United States,
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, using the following scale: Excellent, Good, Fair, Poor, Non-existent. | 14 days | No |
Secondary | 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 | Yes |
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