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

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