Aortic StenosisNCT06749132
Deep Learning-enhanced Personalized Monitoring of Aortic Stenosis - The DETECT-AS Prognostic Study
An observational study of Aortic Stenosis, run by Yale University at 3 sites in United States.
Trial summary
This study will evaluate the validity of a digital biomarker score for precision risk stratification among older adults with aortic sclerosis or mild aortic stenosis (AS) at three US health systems. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transthoracic echocardiogram
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 May 2026to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: US adults aged 65 and older with an echocardiogram within the prior 2-3 years that showed aortic sclerosis without stenosis or mild aortic stenosis (AS).
Who may be able to join
- Age 65 years or older
- Prior transthoracic echocardiogram within the past 2-3 years showing aortic sclerosis without stenosis or mild AS
Who cannot join
- Opted out of research studies
- Non-English speaking
- Any echocardiogram within 24 months of medical record review.
- Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve
- Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device
- Prior heart transplant
Show all 9Show fewer
- History of dementia
- Unable to attend study visit at echocardiogram lab within four years of most recent echocardiogram.
- Documented life expectancy of <1 year or current participation in hospice services
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
The Methodist Hospital Research Institute
Houston, Texas, 77030
Yale New Haven Health System
New Haven, Connecticut, 06519
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
This study will evaluate the validity of a digital biomarker score for precision risk stratification among older adults with aortic sclerosis or mild aortic stenosis (AS) at three US health systems.
- Conditions
- Aortic Stenosis
- Being tested
- Transthoracic echocardiogram
- Keywords
- aortic stenosis, artificial intelligence
- 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.
Transthoracic echocardiogramDiagnostic test
All study participants will undergo a clinical transthoracic echocardiogram (TTE) performed by certified echocardiography technicians. The TTE includes standard transthoracic examination with acquisition of B-mode, color and spectral Doppler images and videos in line with standard echocardiographic guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized change in AV Vmax in m/sec/years
The primary outcome measure is the annualized change in AV Vmax in m/sec/years, defined as the absolute difference between the value on the enrollment and baseline echocardiogram measurement, divided by the time difference between the studies.
Measured: From baseline TTE to TTE performed at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start6 May 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
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.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Icahn School of Medicine at Mount Sinai, The Methodist Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- Rohan Khera, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749132
- Sponsor's protocol ID
- 2000038730
- Other IDs
- R01AG089981
- Status last verified
- May 2026
- First submitted
- 19 Dec 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be made available following publication of primary results.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning-enhanced Personalized Monitoring of Aortic Stenosis - The DETECT-AS Prognostic Study
- ClinicalTrials.gov ID
- NCT06749132
- Acronym / sponsor ID
- 2000038730
- Conditions
- Aortic Stenosis
- Keywords
- aortic stenosis, artificial intelligence
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Icahn School of Medicine at Mount Sinai, The Methodist Hospital Research Institute
- Study start
- 6 May 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 27 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 study will evaluate the validity of a digital biomarker score for precision risk stratification among older adults with aortic sclerosis or mild aortic stenosis (AS) at three US health systems.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- US adults aged 65 and older with an echocardiogram within the prior 2-3 years that showed aortic sclerosis without stenosis or mild aortic stenosis (AS).
Key inclusion criteria (2 listed)
- Age 65 years or older
- Prior transthoracic echocardiogram within the past 2-3 years showing aortic sclerosis without stenosis or mild AS
Key exclusion criteria (9 listed)
- Opted out of research studies
- Non-English speaking
- Any echocardiogram within 24 months of medical record review.
- Prior history of aortic valve replacement or repair, including transcatheter and surgical AVR with either a bioprosthetic or mechanical valve
- Presence of implantable cardiac devices, including permanent cardiac pacer, implantable cardioverter-defibrillator, or left ventricular assist device
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 |
|---|---|---|
| Transthoracic echocardiogramAll study participants will undergo a clinical transthoracic echocardiogram (TTE) performed by certified echocardiography technicians. The TTE includes standard transthoracic examination with acquisition of B-mode, color and spectral Doppler images and videos in line with standard echocardiographic guidelines. | Diagnostic test | – |
Primary outcome
Annualized change in AV Vmax in m/sec/years
Time frame: From baseline TTE to TTE performed at enrollment
The primary outcome measure is the annualized change in AV Vmax in m/sec/years, defined as the absolute difference between the value on the enrollment and baseline echocardiogram measurement, divided by the time difference between the studies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be made available following publication of primary results.
Related trials for Aortic Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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.
Rohan Khera, MD, MS principal investigator
Yale University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Yale University 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 2 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 8 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Annualized change in AV Vmax in m/sec/years (time frame: From baseline TTE to TTE performed at enrollment). 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 8 May 2026.