Heart Valve DiseasesNCT04024566
Rapid Non-invasive Detection of Aortic Stenosis
An observational study of Heart Valve Diseases and Aortic Valve Disease, run by Ventric Health, LLC at 1 site in United States.
Trial summary
Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Heart Valve Diseases, Aortic Valve Disease, Heart Murmurs
- What is being tested?
- Vivio System
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 18 Jul 2022
- Phase
- Observational
- 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 60 to 95 years
- All sexes
- Adult, Older adult
Study population: Severe, symptomatic AS incidence increases with age, so that most patients do not experience symptoms until after age 60. For this reason, to enrich for the population of patients with potential AS, subjects over age 65 will be studied.
Who may be able to join
- Adult subjects >60 years of age
- Ability to understand and sign informed consent
- Willingness to undergo study protocol (in Pasadena CA)
Who cannot join
- Inability to provide informed consent
- History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck)
- History of significant or symptomatic carotid artery disease, or carotid artery stenting or surgery
- History of aortic valve surgery or transcatheter aortic valve replacement
- Absent carotid pulse on initial examination (inability to palpate the carotid pulse)
- Open skin lesions at the site of Vivio application/examination
- Presence of a carotid bruit on examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aortic Stenosis Screening Using the Avicena Vivio System
Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Aortic stenosis (AS) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. When AS is severe, the heart cannot pump adequate amounts of blood into the arterial tree. AS is often silent until the disease is severe. This study compares a rapid test using Vivio to a longer and more expensive test that is the current gold standard for diagnosis of AS, TTE.
Read the detailed description
The study proposed here is a research study to develop the Vivio system for diagnosis of severe AS. The data gathered in this study will be used to optimize the Avicena software algorithm used to make the diagnosis of AS.
The Vivio device is an optical-type tonometer that operates based on capturing the vibrations of the skin due to the arterial pulse pressure wave as it propagates through the underlying carotid vessel. When applied to the neck over the subject's carotid pulse, an arterial waveform (pressure tracing) and heart sounds are sensed, and sent to an iPad using Bluetooth, then sent to Avicena for analysis.
After informed consent subjects will undergo a brief cardiac-focused history and examination. All subjects will have bilateral exams with the Vivio (~5 minutes each) conducted by a study doctor or nurse, and a standard clinical resting TTE conducted by a certified technician. The entire study visit should take 1.5 hours, and there is no follow up.
- Conditions
- Heart Valve Diseases, Aortic Valve Disease, Heart Murmurs
- Being tested
- Vivio System
- Keywords
- echocardiography
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Disease, Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivio SystemDevice
Optical/sensor tonometer applied to the neck over the carotid pulse (bilateral)
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimized algorithm for diagnosis of AS
Data collected in this study will be analyzed by multiple mathematical approaches to develop an optimized algorithm for detection of severe AS
Measured: 2 years
Secondary outcomes (1)
Positive predictive value (PPV) of Vivio in the diagnosis of severe AS
PPV for detecting AS by Vivio compared to PPV for 2D TTE
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start14 Aug 2019
- Primary completion18 Jul 2022
- Study completion18 Jul 2022
Why it stopped: Company changed strategic direction in Oct 2019 (staff changes; no one at company who participated in this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Valve DiseasesStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- 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, Chief Executive Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024566
- Sponsor's protocol ID
- AS20192
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahmed AK, Garberich R, Gossl M, Tindell L, Williams K, Dennis S, Bae R, Soraja P. A novel method of non-invasive screening for patients with aortic stenosis. JACC March 12, 2019, 73 (9 Supplement 1) 1995; DOI:10.1016/S0735-1097(19)32601-4
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
- Aortic Stenosis Screening Using the Avicena Vivio System
- ClinicalTrials.gov ID
- NCT04024566
- Acronym / sponsor ID
- AS20192
- Conditions
- Heart Valve Diseases, Aortic Valve Disease, Heart Murmurs
- Keywords
- echocardiography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company changed strategic direction in Oct 2019 (staff changes; no one at company who participated in this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ventric Health, LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 18 Jul 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.
Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Aortic stenosis (AS) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. When AS is severe, the heart cannot pump adequate amounts of blood into the arterial tree. AS is often silent until the disease is severe. This study compares a rapid test using Vivio to a longer and more expensive test that is the current gold standard for diagnosis of AS, TTE.
Detailed description
The study proposed here is a research study to develop the Vivio system for diagnosis of severe AS. The data gathered in this study will be used to optimize the Avicena software algorithm used to make the diagnosis of AS.
The Vivio device is an optical-type tonometer that operates based on capturing the vibrations of the skin due to the arterial pulse pressure wave as it propagates through the underlying carotid vessel. When applied to the neck over the subject's carotid pulse, an arterial waveform (pressure tracing) and heart sounds are sensed, and sent to an iPad using Bluetooth, then sent to Avicena for analysis.
After informed consent subjects will undergo a brief cardiac-focused history and examination. All subjects will have bilateral exams with the Vivio (~5 minutes each) conducted by a study doctor or nurse, and a standard clinical resting TTE conducted by a certified technician. The entire study visit should take 1.5 hours, and there is no follow up.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Severe, symptomatic AS incidence increases with age, so that most patients do not experience symptoms until after age 60. For this reason, to enrich for the population of patients with potential AS, subjects over age 65 will be studied.
Key inclusion criteria (3 listed)
- Adult subjects >60 years of age
- Ability to understand and sign informed consent
- Willingness to undergo study protocol (in Pasadena CA)
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck)
- History of significant or symptomatic carotid artery disease, or carotid artery stenting or surgery
- History of aortic valve surgery or transcatheter aortic valve replacement
- Absent carotid pulse on initial examination (inability to palpate the carotid pulse)
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 SystemOptical/sensor tonometer applied to the neck over the carotid pulse (bilateral) | Device | – |
Primary outcome
Optimized algorithm for diagnosis of AS
Time frame: 2 years
Data collected in this study will be analyzed by multiple mathematical approaches to develop an optimized algorithm for detection of severe AS
1 secondary outcome
Positive predictive value (PPV) of Vivio in the diagnosis of severe AS
Time frame: 2 years
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.
- BackgroundAhmed AK, Garberich R, Gossl M, Tindell L, Williams K, Dennis S, Bae R, Soraja P. A novel method of non-invasive screening for patients with aortic stenosis. JACC March 12, 2019, 73 (9 Supplement 1) 1995; DOI:10.1016/S0735-1097(19)32601-4
- Individual participant dataSharing planned: No
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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
Chief Executive Officer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases and Aortic Valve Disease, 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 3 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?
Optimized algorithm for diagnosis of AS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024566, which also lists 1 linked publication.
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.