Aortic StenosisNCT06580158
AI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction
An observational study of Aortic Stenosis and Diastolic Dysfunction, run by Mayo Clinic at 1 site in United States.
Trial summary
Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Stenosis, Diastolic Dysfunction
- What is being tested?
- AI-ECG Dashboard and Point of care ultrasound (POCUS)
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2024to Mar 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic.
Who may be able to join
- ≥ 60 years of age must have a clinical scheduled ECG performed.
Who cannot join
- < 59 years of age
- Is not scheduled for a clinical ECG
- Unable to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jae Oh, M.D. contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Jae Oh, M.D., oh.jae@mayo.edu
About this study
Official title: The Clinical Utility of Artificial Intelligence-enabled Electrocardiograms in the Outpatient Practice - Diagnosing Aortic Stenosis and Diastolic Dysfunction
Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.
- Conditions
- Aortic Stenosis, Diastolic Dysfunction
- Being tested
- AI-ECG Dashboard, Point of care ultrasound (POCUS)
- 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.
AI-ECG DashboardDevice
Patients standard of care ECG's will be processed through the AI-ECG Dashboard
Point of care ultrasound (POCUS)Diagnostic test
Patients will undergo a ultrasound to confirm diagnosis of atrial stenosis or diastolic dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic. | Not described Receives: Device: AI-ECG Dashboard; Diagnostic Test: Point of care ultrasound (POCUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with positive AI-ECG
Positive AI-ECG will be determined by the sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: Baseline
Number of studies with reasonable image quality in patients with positive AI-ECG
Image quality will be determined by sonographers at the time of imaging and will be scored on a scale from 1-4:
- Excellent , sufficient for publication
- Good, sufficient for data analysis
- Fair, just enough for data analysis without complete views
- Poor, not usable for data analysis
Measured: Baseline
Secondary outcomes (1)
Number of times the AI ECG and TTE (transthoracic echocardiogram) are statistically comparative
Will be compared using parametric (2-sample t-test) and non-parametric tests (Wilcoxon rank sum test) for continuous variables, and the χ2 test or Fisher exact test for nominal variables. A p-value of < 0.05 will be categorized as significant for the statistical analysis
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start8 Nov 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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 Mayo ClinicThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae K. Oh, M.D., Mayo Clinic
- Investigators
- Jae Oh, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580158
- Sponsor's protocol ID
- 24-000100
- Status last verified
- Jan 2026
- First submitted
- 29 Aug 2024
- Last updated
- 4 Mar 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Utility of Artificial Intelligence-enabled Electrocardiograms in the Outpatient Practice - Diagnosing Aortic Stenosis and Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT06580158
- Acronym / sponsor ID
- 24-000100
- Conditions
- Aortic Stenosis, Diastolic Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Aug 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.
Two recently developed artificial intelligence-enabled electrocardiogram (AI-ECG) models have been developed to detect aortic stenosis (AS) and diastolic dysfunction (DD). AI-ECG for AS has a sensitivity of 78% and specificity of 74%, and AI-ECG for DD has a sensitivity of 83% and specificity of 80%. However, these models have never been prospectively applied to diagnose AS or DD, which may be useful for patients and providers from a diagnostic and prognostic perspective and especially in settings where access to higher- level medical care is limited. In this study, we aim to determine the clinical utility of these AI-ECG models by prospectively applying them to an outpatient cohort and then completing a focused point-of-care ultrasound to evaluate those who are AI-ECG positive for AS and DD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic. | – | Device: AI-ECG Dashboard, Diagnostic Test: Point of care ultrasound (POCUS) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic.
Key inclusion criteria (1 listed)
- ≥ 60 years of age must have a clinical scheduled ECG performed.
Key exclusion criteria (3 listed)
- < 59 years of age
- Is not scheduled for a clinical ECG
- Unable to provide 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 |
|---|---|---|
| AI-ECG DashboardPatients standard of care ECG's will be processed through the AI-ECG Dashboard | Device | Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic. |
| Point of care ultrasound (POCUS)Patients will undergo a ultrasound to confirm diagnosis of atrial stenosis or diastolic dysfunction. | Diagnostic test | Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic. |
Primary outcome
Number of patients with positive AI-ECG
Time frame: Baseline
Positive AI-ECG will be determined by the sensitivity, specificity, positive predictive value, and negative predictive value.
Number of studies with reasonable image quality in patients with positive AI-ECG
Time frame: Baseline
Image quality will be determined by sonographers at the time of imaging and will be scored on a scale from 1-4: 1. Excellent , sufficient for publication 2. Good, sufficient for data analysis 3. Fair, just enough for data analysis without complete views 4. Poor, not usable for data analysis
1 secondary outcome
Number of times the AI ECG and TTE (transthoracic echocardiogram) are statistically comparative
Time frame: Baseline
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 4 Mar 2026.
- 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.
Jae Oh, M.D. contact
Jae Oh, M.D. principal investigator
Mayo Clinic
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 Aortic Stenosis and Diastolic Dysfunction, run by Mayo Clinic 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Mar 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?
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?
Contact Brian Rudquist ((507) 538-5146, Rudquist.Brian@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with positive AI-ECG (time frame: Baseline). The study lists 2 primary outcomes in all. 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 4 Mar 2026.