Aortic StenosisNCT04066634
Vivio AS (Aortic Stenosis) Detection Study
A study testing Vivio System in people with Aortic Stenosis, run by Ventric Health, LLC at 3 sites in United States.
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. 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
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Apr 2019to 29 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.
- Signed informed consent or have a legally authorized representative who provides 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 (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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Morristown Medical Center
Morristown, New Jersey, 07960
Miriam Hospital
Providence, Rhode Island, 02906
St. Francis Hospital
Roslyn, New York, 11576
About this study
Official title: Assessment of the Vivio System as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
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.
Read the 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).
- 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
Also called Electronic stethoscope
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.
| Study group | Role | What they receive |
|---|---|---|
| Assist in Diagnosis | Experimental | 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. Receives: Device: Vivio System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 Hours
Secondary outcomes (4)
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.
Measured: 48 Hours
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.
Measured: 48 Hours
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).
Measured: 48 Hours
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.
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 posted26 Aug 2019
- Study start2 Apr 2019
- Primary completion29 Oct 2019
- Study completion29 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
- 200 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
- NCT04066634
- Sponsor's protocol ID
- VS-001-AS
- Status last verified
- Jul 2021
- First submitted
- 25 Jul 2019
- Last updated
- 2 Aug 2021
- 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 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Vivio System as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT04066634
- Acronym / sponsor ID
- VS-001-AS
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ventric Health, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 26 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.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assist in Diagnosis | Experimental | Device: Vivio SystemThe 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. |
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.
- Signed informed consent or have a legally authorized representative who provides 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 (e.g. due to severe obesity)
- 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 SystemAlso: Electronic stethoscopeThe 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. | Device | Assist in Diagnosis |
Primary outcome
Primary Endpoint - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System
Time frame: 48 Hours
Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System compared to the Expert Physician Panel (EPP).
4 secondary outcomes
Secondary Endpoint 1 - Sensitivity and specificity relative to PCPP detection of heart sounds associated with severe aortic stenosis.
Time frame: 48 Hours
Secondary Endpoint 2 - Correlation of Vivio results to transthoracic echocardiography assessment of aortic stenosis as determined by echocardiography.
Time frame: 48 Hours
Secondary Endpoint 3 - Additional analysis of data to include Likelihood Ratios (LR), Positive Predictive Value (PPV), and Negative Predictive Value (NPV).
Time frame: 48 Hours
Secondary Endpoint 4 - Assessment of type and degree of all heart sounds associated with aortic stenosis (mild/moderate/severe).
Time frame: 48 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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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
3 sites 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 3 sites 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: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 - Sensitivity and specificity of detection of heart sounds associated with severe aortic stenosis by the Vivio System (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 2 Aug 2021.