Skip to main content
OpenTrials
Enrolling by invitation

NCT Number: NCT07827105

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

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.

Enrolling by invitation

Interested in participating?

Request Info

Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Irvine Health

Orange, California, 92868, United States

About this study

This is a prospective, single-arm cohort study which screens approximately 4,000 de-identified 12-lead ECGs by the AK-AVS algorithm. Participants whose ECGs are flagged as positive are approached for consent and undergo a clinical evaluation. Point-of-care ultrasound is additionally performed for the first 10 patients. Confirmatory echocardiography is obtained when clinically indicated by this evaluation, and participants with confirmed AS or other clinically significant incidental findings are referred to the Heart Team for evaluation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

AK-AVS

Device

AI-based ECG algorithm for aortic stenosis detection

Primary outcomes

  1. 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

    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

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

    Time frame: Through study completion, approximately 6 months

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

Secondary outcomes

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

    Time frame: Through study completion, an average of 6 months

    Among participants with a positive AK-AVS result not confirmed as moderate-to-severe aortic stenosis by echocardiogram, proportion attributable to other identifiable cardiac pathologies on echocardiography

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

    Time frame: Through study completion, an average of 6 months

    Among participants with a positive AK-AVS result not confirmed as moderate-to-severe aortic stenosis by echocardiogram, proportion assessed as having findings suggestive of susceptibility to future clinically relevant aortic stenosis

  3. Rate of Clinically Significant Incidental Cardiac Findings on Echocardiography

    Time frame: Through study completion, an average of 6 months

    Proportion of participants undergoing confirmatory echocardiography with incidental findings of heart failure, left ventricular hypertrophy, or other clinically significant cardiac comorbidities warranting further evaluation

  4. Proportion of Confirmed Aortic Stenosis Cases with Absent Murmur

    Time frame: Through study completion, an average of 6 months

    Among participants with echocardiogram-confirmed moderate-to-severe aortic stenosis, proportion presenting without a cardiac murmur on clinical evaluation

  5. Proportion of Confirmed Aortic Stenosis Cases with Absent AS Symptoms

    Time frame: Through study completion, an average of 6 months

    Among participants with echocardiogram-confirmed moderate-to-severe aortic stenosis, proportion presenting without aortic stenosis-related symptoms on clinical evaluation

  6. Proportion of Confirmed Aortic Stenosis Cases with Confounding Conditions Affecting Murmur Detection

    Time frame: Through study completion, an average of 6 months

    Among participants with echocardiogram-confirmed moderate-to-severe aortic stenosis, proportion presenting with conditions known to obscure murmur detection (e.g., low aortic flow, chronic obstructive pulmonary disease)

  7. Diagnostic Concordance of Point-of-Care Ultrasound with Echocardiography for Ruling Out Aortic Stenosis

    Time frame: Up to 2 months from study initiation

    Among participants evaluated during the initial pilot phase, the proportion for whom point-of-care ultrasound (5-chamber view) findings were concordant with confirmatory echocardiography in ruling out aortic stenosis

  8. Time to Diagnosis of Aortic Stenosis from Initial Electrocardiogram

    Time frame: From date of initial ECG to date of confirmatory diagnosis, assessed up to 12 months

    Time interval from the date of the initial ECG used for AK-AVS screening to the date of confirmatory echocardiographic diagnosis of moderate-to-severe aortic stenosis

Interested in participating?

Enrolling by invitation

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

AccurKardia, Inc.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.