Status:
RECRUITING
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
Lead Sponsor:
Peerbridge Health, Inc
Conditions:
Ventricular Ejection Fraction
LVF
Eligibility:
All Genders
18+ years
Brief 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 comp...
Detailed Description
Objective This prospective study benchmarks the accuracy of CorEFS AI software in estimating ejection fraction (EF) severity categories using continuous ECG waveforms from the FDA-cleared Peerbridge C...
Eligibility Criteria
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
Key Trial Info
Start Date :
November 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06699056
Start Date
November 21 2024
End Date
September 1 2025
Last Update
February 11 2025
Active Locations (8)
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1
Orange County Heart Institute
Orange, California, United States, 92868
2
Peerbridge Health
Melbourne, Florida, United States, 32935
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
4
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601