AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
Recruiting · NCT06699056 · Observational (researchers observe without assigning treatment) · Lead sponsor: Peerbridge Health, Inc
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Age ≥ 18 years
- Able and eligible to wear a Holter monitor
Exclusion criteria
- 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
Where it is running
8 locations listed across 6 US states.
- Orange County Heart Institute - Orange, California, United States
- Peerbridge Health - Pasadena, California, 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