AccurKardia, Inc.
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.
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 Sten…
AI-based ECG algorithm for aortic stenosis detection
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