RecruitingNCT06699056

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

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

Sponsor

Peerbridge Health, Inc

Enrollment

1,500 participants

Start Date

Nov 21, 2024

Study Type

OBSERVATIONAL

Conditions

Heart Failure Cardiotoxicity Myocardial Infarction Valvular Heart Disease HFrEF - Heart Failure With Reduced Ejection Fraction Dilated Cardiomyopathy HFpEF - Heart Failure With Preserved Ejection Fraction Ventricular Ejection Fraction LVF LV Dysfunction Atrial Enlargement Conduction Defect Ischemic Heart Disease Syncope Remodeling, Cardiac

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

Min Age: 18 Years

Inclusion Criteria2

Age ≥ 18 years
Able and eligible to wear a Holter monitor

Exclusion Criteria3

Receiving mechanical respiratory or circulatory support, or renal support therapy, at the time of screening or during Visit #1
Any condition that, in the investigator's opinion, could interfere with compliance with the study protocol or pose a safety risk to the participant
History of poor tolerance or severe skin reactions to ECG adhesive materials

Interventions

DEVICE15-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.