Vivio AS (Aortic Stenosis) Detection Study

Aortic Stenosis Clinical Trial

Official title:

Assessment of the Vivio System as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066634
• Other study ID #: VS-001-AS
• Status: Completed
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: October 29, 2019

Study information

• Verified date: July 2021
• Source: Avicena LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 undergo: Vivio data capture, Eko stethoscope capture of heart sounds, Standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel. Recorded sounds from the FDA-approved Eko stethoscope will be presented to an independent expert physician review panel blinded to Vivio and TTE results, to compare diagnosis of severe AS using Eko (auscultation) vs. Vivio (algorithms).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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. Signed informed consent or have a legally authorized representative who provides 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 (e.g. due to severe obesity)

5. History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).

6. History of carotid artery disease or treatment (e.g. unstable carotid plaques that might rupture upon massage or endarterectomy).

7. Open skin lesions at target site of electronic stethoscope/Vivio device examination.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Vivio System
The Vivio Analysis Software is an analysis software that assists in identifying suspected systolic murmurs associated with aortic stenosis. The Vivio Analysis Software is used with the Vivio System, a non-invasive device used for the detection and amplification of sounds from the heart and arteries.

Locations

Country	Name	City	State
United States	Morristown Medical Center	Morristown	New Jersey
United States	Miriam Hospital	Providence	Rhode Island
United States	St. Francis Hospital	Roslyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Avicena LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ancillary Endpoint - Incidence of Adverse Events	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.	48 Hours
Primary	Primary Endpoint - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System	Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System compared to the Expert Physician Panel (EPP).	48 Hours
Secondary	Secondary Endpoint 1 - Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.	Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.	48 Hours
Secondary	Secondary Endpoint 2 - Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography.	Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography.	48 Hours
Secondary	Secondary Endpoint 3 - Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV).	Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV).	48 Hours
Secondary	Secondary Endpoint 4 - Assessment of type and degree of all heart sounds associated with aortic stenosis (mild/moderate/severe).	Assessment of type and degree of all heart sounds associated with aortic stenosis (mild/moderate/severe). The heart sounds associated with severe aortic stenosis using a traditional electronic stethoscope include S1 (normal), S2 (single or paradoxically split) and a late peaking (mid to late systole) diamond shaped, grade 3 or higher murmur. The Vivio system can detect a single component of S2 (aortic) over the carotid but not the pulmonic component or splitting characteristics. It can also detect the nature and timing of the systolic murmur as transmitted through the vascular system to the carotid. The heart sounds associated with severe aortic stenosis include S1 (normal), presence or absence of S2. Less severe aortic stenosis is characterized by an early to mid-peaking diamond shape murmur with a soft but present aortic component of S2.	48 Hours