ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting

NCT07827105 | Enrolling By Invitation FDA Device

• 1 other identifier: AK-AVS
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Stenosis

Keywords

Aortic stenosis; AS; aortic valve; cardiovascular; ECG; AI algorithm; echocardiography; electrocardiogram

Outcome Measures

Primary Outcomes (2)

• Sensitivity of AK-AVS Algorithm for Detection of Moderate-to-Severe Aortic Stenosis as Confirmed by Echocardiography

  Proportion of participants with an echocardiogram-confirmed diagnosis of moderate-to-severe aortic stenosis among those with a positive result from the AK-AVS algorithm, calculated with a 95% confidence interval

  Through study completion, an average of 6 months

• Positive Predictive Value of AK-AVS Algorithm-Positive Results as Confirmed by Echocardiography

  Proportion of algorithm-positive results confirmed as true moderate-to-severe aortic stenosis by echocardiogram, out of all algorithm-positive results evaluated

  Through study completion, approximately 6 months

Secondary Outcomes (8)

• Relation of False-Positive AK-AVS Results to Other Cardiac Pathologies

  Through study completion, an average of 6 months

• Susceptibility of False-Positive AK-AVS Results to Future Clinically Relevant Aortic Stenosis

  Through study completion, an average of 6 months

• Rate of Clinically Significant Incidental Cardiac Findings on Echocardiography

  Through study completion, an average of 6 months

• Proportion of Confirmed Aortic Stenosis Cases with Absent Murmur

  Through study completion, an average of 6 months

• Proportion of Confirmed Aortic Stenosis Cases with Absent AS Symptoms

  Through study completion, an average of 6 months

Interventions

AK-AVS DEVICE

AI-based ECG algorithm for aortic stenosis detection

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants will be drawn from patients 65 years of age or older with 12-lead ECGs on file at a primary care outpatient office, urgent care facility, or emergency department. Eligible ECGs, acquired within the prior 6 months, will be identified through electronic health record review and randomly selected by the principal investigator for AK-AVS screening.

You may qualify if:

• 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

You may not qualify if:

• ECG Poor Quality (as indicated by cardiology information system)
• 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

Sponsors & Collaborators

• AccurKardia, Inc.: lead

Study Sites (1)

UC Irvine Health

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: August 21, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Locations

US (1)