ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting
Key facts
- Where
- Orange, United StatesSee the site
Where in United States
- UC Irvine HealthOrange, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- AccurKardia, Inc.
- Trial code
- NCT07827105
- Record updated
- 18 September 2026
- Original description
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been diagnosed. The main question it aims to answer is if AK-AVS can correctly identify participants who have undiagnosed moderate-to-severe aortic stenosis, based on a routine heart tracing (electrocardiogram).Read full original descriptionShow less
The goal of this observational study is to learn whether AccurKardia's AK-AVS algorithm can help identify moderate-to-severe aortic stenosis (AS), a narrowing of the heart's aortic valve, in older adults who have not yet been diagnosed. The main question it aims to answer is if AK-AVS can correctly identify participants who have undiagnosed moderate-to-severe aortic stenosis, based on a routine heart tracing (electrocardiogram).
Approximately 4,000 electrocardiograms (ECGs) already collected as part of routine primary care, urgent care, or emergency room visits will be reviewed by the AK-AVS algorithm. Patients whose ECGs are flagged as showing a possible sign of aortic stenosis will be invited to complete a symptom questionnaire, a physical exam, and heart ultrasound (echocardiogram) to confirm whether aortic stenosis is present.
Inclusion: ECGs from primary care or ER visits; ECGs must include all relevant parameters for AK-AVS intake; Patients aged 65 and older at the time of the ECG; Subgroup analysis:; Patients with Insulin Resistance (pre-diabetic), Diabetes Mellitus, and Chronic Kidney Disease; Patients with hypertension.
Exclusion: Patients already seen by cardiology, to effectively exclude:; Pacemaker / Paced rhythm Ejection fraction (EF) less than 40% Left ventricular hypertrophy (LVH) Prior diagnosis of Aortic Stenosis Prior diagnosis of heart failure Prior myocardial infraction (MI) Prior cardiac surgery; ECG Poor Quality (as indicated by cardiology information system).