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

Part of paid clinical trials in Orange, California.

Sponsor
AccurKardia, Inc.
Study ID
NCT07827105
Status
Enrolling By Invitation

Conditions

  • Aortic Stenosis

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • AK-AVS — DEVICE
    AI-based ECG algorithm for aortic stenosis detection

Study Details

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.

Key Dates

First listed
Sep 18, 2026
Start date
Aug 21, 2026
Status verified
Sep 2026
Primary completion
Feb 28, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
4,000 participants (estimated)

Primary Outcome Measure

Sensitivity of AK-AVS Algorithm for Detection of Moderate-to-Severe Aortic Stenosis as Confirmed by Echocardiography [ Time Frame: Through study completion, an average of 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC Irvine HealthOrangeCalifornia92868-

Find similar trials in Orange, CA

By research site
UC Irvine Health· Orange, CA

Related Studies