Aortic Stenosis
Conditions
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, standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel
Interventions
DEVICEVivio System
The Vivio System is an electronic auscultatory device and optical sensor, plus software application intended to provide support to the physician in the evaluation of heart sounds in patients. The product will analyze the acoustic signals of the heart and signals from a captured arterial (carotid) waveform. The analysis procedure will identify and analyze specific heart sounds and arterial waveform features captured by the Vivio device, to devise a scoring system for severe aortic stenosis.
Sponsors
Avicena LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
No masking required
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adult subjects (21 years of age or older). 2. Referred for transthoracic echocardiography by physician/primary care provider/cardiologist. 3. Willing and able to participate in all study evaluations and allow access to medical testing and records. 4. Ability to understand and sign an informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.
Exclusion criteria
1. Acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical circulatory support. 2. Need for bedside echocardiogram (inpatient). 3. Prosthetic device previously implanted at aortic valve position. 4. Inability to palpate carotid pulse 5. History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck). 6. History of significant carotid artery disease or treatment (surgery, stenting, \> 50% stenosis in both left and right carotid artery). 7. Open skin lesions at target site of Vivio examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint - Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis. | 48 hours | Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study | 48 hours | Incidence of Adverse Events: Summary of all reported adverse events during the study. Events will be summarized by seriousness (e.g. serious vs. non-serious), attribution (e.g. device vs. procedure vs. comorbidity) based upon site reported data. |
Countries
United States
Outcome results
None listed