Status:
COMPLETED
Vivio AS (Aortic Stenosis) Detection Study
Lead Sponsor:
Avicena LLC
Conditions:
Aortic Stenosis
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Evaluate the sensitivity and specificity of the Vivio System when used as an aid in the identification of heart sounds associated with severe aortic stenosis.
Detailed Description
Prospective, non-randomized, multi-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 3 sites. Up to 10 roll-in subjects per site. Enrolled subjects will u...
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.
- Signed informed consent or have a legally authorized representative who provides 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 (e.g. due to severe obesity)
- History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).
- History of carotid artery disease or treatment (e.g. unstable carotid plaques that might rupture upon massage or endarterectomy).
- Open skin lesions at target site of electronic stethoscope/Vivio device examination.
Key Trial Info
Start Date :
April 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04066634
Start Date
April 2 2019
End Date
October 29 2019
Last Update
August 2 2021
Active Locations (3)
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1
Morristown Medical Center
Morristown, New Jersey, United States, 07960
2
St. Francis Hospital
Roslyn, New York, United States, 11576
3
Miriam Hospital
Providence, Rhode Island, United States, 02906