Clinical Trials

Inclusion Criteria:

Must meet any one of the following criteria and Age ≥ 18:

• (ECG-AI CAD) Has an ECG within 30 days prior to or on the same day as an echocardiographic assessment of 16/17 segments regional wall motion abnormalities (target N = 5,000 patients per site)

• (ECG-AI HTN-HHD)

  • HTN: In patients receiving continuous primary care, have ECGs within ±1 year of subsequent primary care BP recordings. (target N = 7,000 patients per site)

  • HHD: Has an ECG within 30 days prior to or on the same day as echocardiogram that contains the following measurements (target N = 5,000 patients per site):

    • Left ventricular mass index (LVMI)

    • Left atrial volume index (LAVI)

• (ECG-AI DD) Has an ECG within 30 days prior to or on the same day as an echocardiogram that contains all six of the following measurements (target N = 5,000 patients per site):

  • Septal e’ velocity

  • E/e’

  • Tricuspid regurgitation velocity

  • Left atrial volume index

  • Mitral E/A ratio

  • Left ventricular ejection fraction

• ECG-AI LEF V2) Has an ECG within 30 days prior to or on the same day as an echocardiogram that contains the following measurements (target N = 6,000 patients per site):

  • Left ventricular ejection fraction by biplane Simpson’s method (LVEF)

• (ECG-AI IAF) In patients receiving continuous primary care, have a nonAF ECG that has a follow up primary care visit 3 years after the ECG under consideration (target N = 10,000 per site)

Exclusion Criteria:

• Subjects who meet any of the following exclusion criteria will not be included in the study:

  • No subject consent obtained, or no IRB waiver granted.

  • Subjects who only have ECGs with signals shorter than 10 seconds or that are not interpretable.

  • Additional exclusion criteria for each SaMD studied will be applied post-data collection, using deidentified clinical data, by the analysis team. These are detailed in the statistical analysis plans for each algorithm.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/14/2025. Questions regarding updates should be directed to the study team contact.