Aortic StenosisNCT04068402
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
A study testing Vivio System in people with Aortic Stenosis, run by Ventric Health, LLC at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Vivio System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2019to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Aortic Stenosis
- Being tested
- Vivio System
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivio SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Vivio System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours
Secondary outcomes (1)
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start27 Jun 2019
- Primary completion31 Aug 2019
- Study completion30 Oct 2019
Why it stopped: Company changed strategic direction in Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ventric Health, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Brady, JD, Study director, Ventric Health, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068402
- Sponsor's protocol ID
- VS-001-AO
- Status last verified
- Jan 2021
- First submitted
- 25 Jul 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Vivio System Algorithm as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04068402
- Acronym / sponsor ID
- VS-001-AO
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company changed strategic direction in Oct 2019
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ventric Health, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Vivio System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivio SystemThe 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. | Device | Treatment |
Primary outcome
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.
1 secondary outcome
Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Brady, JD study director
Ventric Health, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivio System in people with Aortic Stenosis, run by Ventric Health, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022; AzTrials last refreshed its copy on 27 Oct 2026.