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

Recruitingn/aAges 18 Years - anyAllPeerbridge Health, Inc
NCT06699056 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 transthor

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📋 Eligibility rules (as published)
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
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What it tests

  • 15-minutes of sitting during COR ECG Acquistion
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Where

8 sites
Orange County Heart Institute
Orange, United States
Peerbridge Health
Pasadena, United States
Henry Ford Hospital
Detroit, United States
Hackensack University Medical Center
Hackensack, United States
Mount Sinai Hospital
New York, United States
Moses H. Cone Memorial Hospital
Greensboro, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, United States
South Heart Clinic
Weslaco, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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