Patients With an Indication for an Echocardiographic Examination With Suspicion of Valcular Heart DiseasePOCNCT06717373
Point-of-Care Echocardiography in Patients With Known or Suspected Aortic Stenosis
A study testing AutoAS in people with Patients With an Indication for an Echocardiographic Examination With Suspicion of Valcular Heart Disease, run by Caption Health, Inc. at 1 site in United States.
Trial summary
This is a prospective clinical trial intended to capture echocardiographic images in patients clinically indicated for an echocardiographic examination using an additional Point of Care Ultrasound device . The images collected will be used to test and possibly validation an AI base Aortic Valve Stenosis algorithm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With an Indication for an Echocardiographic Examination With Suspicion of Valcular Heart Disease
- What is being tested?
- AutoAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2025to 16 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for an echocardiographic examination
- Patients ≥18 years old
- Patient with known or suspected valve disease based on medical history
Who cannot join
- Patients with artificial aortic valves
- Unable to lie flat for study
- Patients experiencing a known or suspected acute cardiac event
- Patients unwilling or unable to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective clinical trial intended to capture echocardiographic images in patients clinically indicated for an echocardiographic examination using an additional Point of Care Ultrasound device . The images collected will be used to test and possibly validation an AI base Aortic Valve Stenosis algorithm
Read the detailed description
This is a non-randomized, un-blinded single-arm study in patients scheduled for a standard echocardiographic examination. Participants will be scanned by a sonographer (Study Exam) and 6 standard views will be obtained using both the ultrasound systems: PLAX, PSAX-AV, AP4, AP2, AP3 and AP5 .
The patient will undergo their scheduled echocardiographic examination either before or after the study examinations.
The findings from the clinically indicated echocardiographic examination will be used as a gold standard for the presence/absence and severity of aortic stenosis.
The first 45 patients, 15 with mild, 15 with moderate and 15 with severe AS, will be used for testing and possible fine-tuning the AutoAS algorithm for each Study Device, and the remaining up to 155 patients for each Study Device will be used for clinical validation of the algorithm. Because these first 45 patients will only be used for possible fine-tuning the AutoAS algorithm, they will be excluded from endpoint analysis.
- Being tested
- AutoAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoASDevice
AutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | There is no investigational device being used. Devices to be used are Vscan Air and Venue Ultrasound systems Receives: Device: AutoAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
The primary endpoints are the sensitivity and specificity of the Caption AutoAS algorithm for the absence (none/mild AS) or presence (moderate/severe AS) of AS relative to that indicated in the echocardiographic examination.
Measured: At the time of the examination
Secondary outcomes (1)
Subgroup analysis of outcome 1
Subgroup Analyses: Sensitivity and specificity will be calculated for the following sub-groups. BMI group (< 25, ≥ 25-30, ≥ 30), sex, and age (<65, ≥65)
Measured: At the time of the examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start7 Feb 2025
- Primary completion16 May 2025
- Study completion16 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With an Indication for an Echocardiographic Examination With Suspicion of Valcular Heart DiseaseStudies 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
- Model description
- This is a prospective, non-randomized, un-blinded study in patients scheduled for a standard echocardiographic examination.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caption Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Akhil Narang, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717373
- Sponsor's protocol ID
- CH_AutoAS_2024
- Acronym
- POC
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Echocardiography in Patients With Known or Suspected Aortic Stenosis
- ClinicalTrials.gov ID
- NCT06717373
- Acronym / sponsor ID
- POC / CH_AutoAS_2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Caption Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 5 Dec 2024 (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.
This is a prospective clinical trial intended to capture echocardiographic images in patients clinically indicated for an echocardiographic examination using an additional Point of Care Ultrasound device . The images collected will be used to test and possibly validation an AI base Aortic Valve Stenosis algorithm
Detailed description
This is a non-randomized, un-blinded single-arm study in patients scheduled for a standard echocardiographic examination. Participants will be scanned by a sonographer (Study Exam) and 6 standard views will be obtained using both the ultrasound systems: PLAX, PSAX-AV, AP4, AP2, AP3 and AP5 .
The patient will undergo their scheduled echocardiographic examination either before or after the study examinations.
The findings from the clinically indicated echocardiographic examination will be used as a gold standard for the presence/absence and severity of aortic stenosis.
The first 45 patients, 15 with mild, 15 with moderate and 15 with severe AS, will be used for testing and possible fine-tuning the AutoAS algorithm for each Study Device, and the remaining up to 155 patients for each Study Device will be used for clinical validation of the algorithm. Because these first 45 patients will only be used for possible fine-tuning the AutoAS algorithm, they will be excluded from endpoint analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, non-randomized, un-blinded study in patients scheduled for a standard echocardiographic examination.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: AutoASThere is no investigational device being used. Devices to be used are Vscan Air and Venue Ultrasound systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for an echocardiographic examination
- Patients ≥18 years old
- Patient with known or suspected valve disease based on medical history
Key exclusion criteria (4 listed)
- Patients with artificial aortic valves
- Unable to lie flat for study
- Patients experiencing a known or suspected acute cardiac event
- Patients unwilling or unable to give written informed consent
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 |
|---|---|---|
| AutoASAutoAS is an artificial intelligence algorithm that will be tested retrospectively on the images acquired as part of the study | Device | Single Arm |
Primary outcome
Sensitivity and Specificity
Time frame: At the time of the examination
The primary endpoints are the sensitivity and specificity of the Caption AutoAS algorithm for the absence (none/mild AS) or presence (moderate/severe AS) of AS relative to that indicated in the echocardiographic examination.
1 secondary outcome
Subgroup analysis of outcome 1
Time frame: At the time of the examination
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 14 Jul 2026.
- Individual participant dataSharing planned: No
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.
Akhil Narang, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoAS in people with Patients With an Indication for an Echocardiographic Examination With Suspicion of Valcular Heart Disease, run by Caption Health, Inc. 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 4 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 14 Jul 2026. 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 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?
Sensitivity and Specificity (time frame: At the time of the examination). 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 14 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.