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

Last updated: February 9, 2025
Sponsor: Peerbridge Health, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Coronary Artery Disease

Angina

Treatment

15-minutes of sitting during COR ECG Acquistion

Clinical Study ID

NCT06699056
PBH-COREFS-1-A
PBH-COREFS-1-A
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Able and eligible to wear a Holter monitor

Exclusion

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 compliancewith the study protocol or pose a safety risk to the participant

  • History of poor tolerance or severe skin reactions to ECG adhesive materials

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: 15-minutes of sitting during COR ECG Acquistion
Phase:
Study Start date:
November 21, 2024
Estimated Completion Date:
September 30, 2025

Study 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 Cor® ECG device, calibrated to the American Society of Echocardiography (ASE) scale.

Background Heart failure (HF) remains a significant public health issue, particularly in older adults (75+), with high morbidity and mortality rates. Half of HF cases involve reduced EF (HFrEF), a condition associated with a 75% five-year mortality rate. Despite advancements in HF management, accessible, low-cost EF monitoring is lacking.

Echocardiography (Echo) is the gold standard for EF measurement but is limited in ambulatory and home settings. Continuous ECG wearables like the Peerbridge Cor® offer a promising alternative, providing high diagnostic yield, low wear burden, and real-time EF estimation. Previous studies (References 1-11) demonstrate the potential of AI-enabled ECG analysis in EF prediction, with accuracies up to 91.4% and AUCs of 0.94 in estimating EF severity.

Successful demonstration of the proposed endpoints to clinically acceptable statistical thresholds will provide a new and alternative capability for EF severity assessments compared to ultrasound, MRI, and other imaging modalities where access is limited.

Hypothesis Specific ECG changes may identify left ventricular dysfunction (LVSD) and predict EF severity, enabling low-burden, cost-effective EF monitoring in high-risk populations.

Study Design

Participant Enrollment and Setup

Participants will receive the Peerbridge Cor® wearable, with data collection occurring through:

In-clinic setup: Study staff apply and initiate device use. Patient Home Setup (PHS): Telehealth guidance for independent device application (20% of participants).

Subprotocols

A: 30 minutes of Cor® ECG recording; 15 minutes analyzed. B: Up to 7 days of Cor® device use with periodic 15-minute sitting sessions. EF Reference Standard EF severity will be determined via FDA-cleared transthoracic echocardiography (TTE), using the Simpson's Bi-Plane Method.

Data Collection

Peerbridge Cor® ECG Data: 30 minutes recorded; 15 minutes analyzed in 5-minute segments.

Echo Study: Conducted before or during Cor® recording. 12-Lead ECG: Simultaneous recording with the Cor® device. Participants log sessions using the Cor® device's Event button. De-identified medical histories will support subgroup analyses.

Endpoints Agreement between Cor® ECG-derived EF severity and Echo results will be assessed across ASE-defined categories (Normal, Mild, Moderate, Severe). Positive predictive value (PPV) adjusted for prevalence will be calculated.

This streamlined protocol validates CorEFS software for reliable, cost-effective EF monitoring and clinical decision support.

Connect with a study center

  • Orange County Heart Institute

    Orange, California 92868
    United States

    Active - Recruiting

  • Peerbridge Health

    Melbourne, Florida 32935
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Mount Sinai Hospital

    New York, New York 10019
    United States

    Active - Recruiting

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina 27401
    United States

    Active - Recruiting

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78705
    United States

    Active - Recruiting

  • South Heart Clinic

    Weslaco, Texas 78596
    United States

    Active - Recruiting

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