AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor

Condition(s) studied

Investigational drug(s) / intervention(s)

15-minutes of sitting during COR ECG Acquistion: Participants will follow a standardized protocol during a 15-minute seated session using the Peerbridge COR™ device. Participants will sit comfortably in an upright chair with a straight back; armrests are optional. Their feet must remain flat on the floor with legs uncrossed to ensure unobstructed blood flow and a stable posture. Arms should be relaxed and placed in their lap, on a flat surface (e.g., table), or on the armrest, ensuring they are not tensed or elevated. Participants will maintain a straight back with relaxed shoulders throughout the session. To begin, participants will press the Event Button on the Peerbridge COR™ mobile device, marking the start of the session. They will remain seated in this position for 15 minutes. At the end of the session, participants will press the Event Button again to mark the conclusion of the seated event. This protocol ensures consistent data collection across all participants.

Study summary

This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood.

In this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.

Eligibility

Primary outcome measure(s)

• Agreement of CorEFS Software EF Severity Categories Using Peerbridge COR™ ECG Data with ASE EF Severity Categories Established by Ultrasound Echocardiography — Through study completion, average of 9 months.
  The primary endpoint of this trial is to demonstrate substantial agreement between EF severity categories determined by the CorEFS Software using 5 minutes of Peerbridge COR™ ECG data and the subject's EF severity category established through ultrasound echocardiography, the gold standard for EF classification. The study includes four co-primary endpoints, representing agreement measures within each of the four EF severity categories defined by the American Society of Echocardiography (ASE) Scale (Normal, Mildly Abnormal, Moderately Abnormal, Severely Abnormal). For each category the endpoint is the proportion of participants correctly classified by the test device relative to the reference standard. The goal is to demonstrate at least 80% agreement within each EF severity category.

Trial sites (8)

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