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Vivio AS (Aortic Stenosis) Detection Study

Primary Purpose

Aortic Stenosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivio System
Sponsored by
Avicena LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Stenosis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Morristown Medical Center
  • St. Francis Hospital
  • Miriam Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Assist in Diagnosis

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
July 25, 2019
Last Updated
July 28, 2021
Sponsor
Avicena LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04066634
Brief Title
Vivio AS (Aortic Stenosis) Detection Study
Official Title
Assessment of the Vivio System as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
October 29, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avicena LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assist in Diagnosis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vivio System
Other Intervention Name(s)
Electronic stethoscope
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Endpoint - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System
Description
Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System compared to the Expert Physician Panel (EPP).
Time Frame
48 Hours
Secondary Outcome Measure Information:
Title
Secondary Endpoint 1 - Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.
Description
Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.
Time Frame
48 Hours
Title
Secondary Endpoint 2 - Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography.
Description
Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography.
Time Frame
48 Hours
Title
Secondary Endpoint 3 - Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV).
Description
Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV).
Time Frame
48 Hours
Title
Secondary Endpoint 4 - Assessment of type and degree of all heart sounds associated with aortic stenosis (mild/moderate/severe).
Description
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.
Time Frame
48 Hours
Other Pre-specified Outcome Measures:
Title
Ancillary Endpoint - Incidence of Adverse Events
Description
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.
Time Frame
48 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Brady, JD
Organizational Affiliation
Avicena LLC
Official's Role
Study Director
Facility Information:
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

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Vivio AS (Aortic Stenosis) Detection Study

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