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AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
Sponsor: Peerbridge Health, Inc
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.
Official title: AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Using COR ECG Wearable Monitor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2024-11-21
Completion Date
2025-09
Last Updated
2025-02-11
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (8)
Orange County Heart Institute
Orange, California, United States
Peerbridge Health
Melbourne, Florida, United States
Henry Ford Hospital
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
South Heart Clinic
Weslaco, Texas, United States