- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04068402
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
July 18, 2022 updated by: Avicena LLC
Optimization of the Vivio System Algorithm as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
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
Study Overview
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
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Michigan
-
Grand Rapids, Michigan, United States, 49503
- Spectrum Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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.
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study
Time Frame: 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.
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sean Brady, JD, Avicena LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2019
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
October 30, 2019
Study Registration Dates
First Submitted
July 25, 2019
First Submitted That Met QC Criteria
August 22, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
July 20, 2022
Last Update Submitted That Met QC Criteria
July 18, 2022
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VS-001-AO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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