A Study Of Heart Disease Using AI-Enabled Electrocardiography And Focused Cardiac Ultrasound

The percentage will be calculated as the number of participants whose AI-ECG results indicate a positive finding and are subsequently confirmed by echocardiography, divided by the total number of participants assessed, multiplied by 100.

Number of patients with positive AI-ECG detection for left-right sided SHD, defined as any of the following: LVEF <50%, >moderate right ventricular systolic dysfunction, >moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension (right ventricular systolic pressure > 50 mmHg), or elevated left-sided filling pressure.

Diagnostic performance of the AI-ECG will be determined by the accurate diagnosis of cardiomyopathy (left ventricular ejection fraction [LVEF] ≤50% or 10% or more decline in LVEF) or clinically significant structural heart disease (SHD; ≥ moderate right ventricular systolic dysfunction, ≥ moderate aortic, mitral, or tricuspid valve regurgitation or stenosis, pulmonary hypertension [right ventricular systolic pressure > 50 mmHg], or myocardial disease such as hypertrophic cardiomyopathy) in pregnant patients and those up to 6 weeks postpartum compared to standard of care.

Number of false positive AI-ECG results will be determined by the number of positive AI-ECG results proven false from an echocardiography

The number of positive AI-ECG results for HCM will be based on how many patient ECGs indicate a possible diagnosis of HCM

The number of positive AI-ECG results for CHD will be based on how many patient ECGs indicate a possible diagnosis of CHD

Proportion of patients by age group (30-39, 40-49, 50-65, 65-74, and 75 years and older) to receive a diagnosis from ultrasound that is confirmed by a comprehensive diagnostic work up.

Proportion of total patients to receive a diagnosis based on screening with 6 lead ECG will be determined by the number of patients to have a correct diagnosis using the 6 lead ECG confirmed by echocardiogram compared to the total number of patients.

Proportion of total patients to receive a diagnosis based on screening with 12 lead ECG will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG confirmed by echocardiogram compared to the total number of patients.

Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG with adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG with adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.

Proportion of total patients to receive a diagnosis based on screening with 12 lead only AI-ECG without adjunctive FoCUS will be determined by the number of patients to have a correct diagnosis using the 12 lead ECG without adjunctive FoCUS confirmed by standard of care echocardiogram compared to the total number of patients.

Number of non-cardiac adverse events can include hypertensive disorders of pregnancy (gestational hypertension, pre-eclampsia, eclampsia), preterm delivery, gestational diabetes, small for gestational age delivery, placental abruption, and pregnancy loss.