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Aortic StenosisNCT07827105

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

An observational study of Aortic Stenosis, run by AccurKardia, Inc. at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Aortic Stenosis
What is being tested?
AK-AVS
Type of treatment
Medical device
How many people
4,000 participants
Where
1 siteUnited States
Study dates
21 Aug 2026to Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • UC Irvine Health

    Orange, California, 92868

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions
Aortic Stenosis
Being tested
AK-AVS
Keywords
Aortic stenosis, AS, aortic valve, cardiovascular, ECG, AI algorithm, echocardiography, electrocardiogram
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK-AVSDevice

    AI-based ECG algorithm for aortic stenosis detection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through study completion, an average of 6 months

  2. 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

    Measured: Through study completion, approximately 6 months

Secondary outcomes (8)

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

    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

    Measured: Through study completion, an average of 6 months

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

    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

    Measured: Through study completion, an average of 6 months

  3. Rate of Clinically Significant Incidental Cardiac Findings on Echocardiography

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

    Measured: Through study completion, an average of 6 months

  4. Proportion of Confirmed Aortic Stenosis Cases with Absent Murmur

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

    Measured: Through study completion, an average of 6 months

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

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

    Measured: Through study completion, an average of 6 months

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

    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)

    Measured: Through study completion, an average of 6 months

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

    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

    Measured: Up to 2 months from study initiation

  8. Time to Diagnosis of Aortic Stenosis from Initial Electrocardiogram

    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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2026
  2. Study start21 Aug 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07827105
Sponsor's protocol ID
AK-AVS
Status last verified
Sep 2026
First submitted
14 Sep 2026
Last updated
18 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Stenosis, run by AccurKardia, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07827105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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