An observational study in Aortic Stenosis and Diastolic Dysfunction, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Mayo Clinic · Observational
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are completing an outpatient electrocardiogram (ECG) at the Mayo Clinic.
Exclusion Criteria:
Device: AI-ECG Dashboard · Diagnostic Test: Point of care ultrasound (POCUS)
Patients standard of care ECG's will be processed through the AI-ECG Dashboard
Patients will undergo a ultrasound to confirm diagnosis of atrial stenosis or diastolic dysfunction.
Number of patients with positive AI-ECG
Positive AI-ECG will be determined by the sensitivity, specificity, positive predictive value, and negative predictive value.
Time frame: 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: 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
Time frame: Baseline
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
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mayo Clinic