COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable

A 30-minute COR ECG recording will be performed, including 15 minutes of continuous sitting data used for clinical indication analysis through CardioMIND software. Data collection can occur in-clinic, via PHS, or using a shipped device with telehealth support. Sleep, HRV, and AFIB risk analysis will not be included.

Subjects will undergo 24 hours of COR ECG recording, which must include at least one 15-minute unsupervised sitting session. Data analysis will include sleep patterns, HRV, and AFIB risk. ECG acquisition may take place in-clinic, via Patient Home Setup (PHS), or with a shipped device.

COR 1.0 ECG recordings will be conducted over 2 to 7 days, with at least one 15-minute unsupervised sitting session. At least 25% of randomly selected trial participants subjects will also wear a cleared wrist or finger device to track SpO2 during sleep. PI or Sub-Investigator will assign the number of wear days to the subject. The analysis will include sleep data, HRV, and AFIB risk assessment.

COR 2.0 (CORMDX) recordings will be conducted over 2 to 14 days, with at least one 15-minute unsupervised sitting session. At least 25% of randomly selected trial participants will also wear a cleared wrist or finger device to track SpO2 during sleep nights. PI or Sub-Investigator will assign the number of wear days to the subject. The analysis will include sleep data, HRV, and AFIB risk assessment.

Subjects will complete a 30-minute CORMDx (COR 2.0) ECG recording, with 15 minutes of continuous sitting data used for clinical indication analysis. Sleep, HRV, and AFIB risk analysis will not be performed.

A 30-minute COR 2.0 ECG recording will be completed, along with a 12-lead resting ECG using an FDA-cleared reference device. Sleep, HRV, and AFIB analysis will not be performed.

A 40-minute COR 2.0 recording will be conducted in two phases: 15 minutes of upright sitting and 15 minutes in a supine position. Hemodynamic monitoring, including blood pressure, cardiac output, and stroke volume variation, will be conducted using an FDA-cleared reference device. No sleep, HRV, or AFIB analysis will be performed.

Subjects will undergo a 40-minute COR 2.0 recording, followed by a 40-minute COR 1.0 recording. Hemodynamic monitoring using an FDA-cleared reference device will be performed during both sessions. The transition between devices must occur within 60 minutes if the same adhesive is reused. Sleep, HRV, and AFIB analysis will not be performed.