Status:
WITHDRAWN
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
Lead Sponsor:
Avicena LLC
Conditions:
Aortic Stenosis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis
Detailed Description
Prospective, non-randomized, single-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 1 site Enrolled subjects will undergo: Vivio system data capture, ...
Eligibility Criteria
Inclusion
- Adult subjects (21 years of age or older).
- Referred for transthoracic echocardiography by physician/primary care provider/cardiologist.
- Willing and able to participate in all study evaluations and allow access to medical testing and records.
- Ability to understand and sign an informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.
Exclusion
- Acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical circulatory support.
- Need for bedside echocardiogram (inpatient).
- Prosthetic device previously implanted at aortic valve position.
- Inability to palpate carotid pulse
- History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).
- History of significant carotid artery disease or treatment (surgery, stenting, \> 50% stenosis in both left and right carotid artery).
- Open skin lesions at target site of Vivio examination.
Key Trial Info
Start Date :
June 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04068402
Start Date
June 27 2019
End Date
October 30 2019
Last Update
July 20 2022
Active Locations (1)
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1
Spectrum Health
Grand Rapids, Michigan, United States, 49503