Actively Recruiting
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
Led by Peerbridge Health, Inc · Updated on 2025-02-11
1500
Participants Needed
8
Research Sites
40 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able and eligible to wear a Holter monitor
You will not qualify if you...
- Receiving mechanical respiratory, circulatory, or renal support at screening or Visit #1
- Any condition that could interfere with study compliance or pose safety risks
- History of poor tolerance or severe skin reactions to ECG adhesive materials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Orange County Heart Institute
Orange, California, United States, 92868
Actively Recruiting
2
Peerbridge Health
Melbourne, Florida, United States, 32935
Not Yet Recruiting
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
4
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
5
Mount Sinai Hospital
New York, New York, United States, 10019
Actively Recruiting
6
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States, 27401
Actively Recruiting
7
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705
Actively Recruiting
8
South Heart Clinic
Weslaco, Texas, United States, 78596
Actively Recruiting
Research Team
S
Sandeep Gulati, PhD
CONTACT
C
Chris Darland, MBA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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