Back to resultsVivio AS (Aortic Stenosis) Algorithm Optimization Study
Primary Purpose
Aortic Stenosis
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivio System
Sponsored by
About this trial
This is an interventional diagnostic trial for Aortic Stenosis
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.
- 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:
- 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.
Sites / Locations
- Spectrum Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
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 Outcome Measures
Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04068402
Brief Title
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
Official Title
Optimization of the Vivio System Algorithm as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Company changed strategic direction in Oct 2019
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
October 30, 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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
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)
Masking Description
No masking required
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vivio System
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study
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.
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:
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.
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
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
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