An observational study in Aortic Stenosis, sponsored by AccurKardia, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by AccurKardia, Inc. · Observational
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.
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →AccurKardia, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subgroup analysis:
Exclusion Criteria:
Pacemaker / Paced rhythm (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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AI-based ECG algorithm for aortic stenosis detection
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
Time frame: 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
Time frame: Through study completion, approximately 6 months
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
Time frame: Through study completion, an average of 6 months
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
Time frame: Through study completion, an average of 6 months
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
Time frame: Through study completion, an average of 6 months
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
Time frame: Through study completion, an average of 6 months
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
Time frame: Through study completion, an average of 6 months
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)
Time frame: Through study completion, an average of 6 months
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
Time frame: Up to 2 months from study initiation
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
Time frame: From date of initial ECG to date of confirmatory diagnosis, assessed up to 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Feb 2027, 6 months after the start.
Of 37 industry-sponsored observational studies under Aortic Valve Stenosis, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 47. This study's planned 6 months is below that.
Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
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AccurKardia, Inc.