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

May 28, 2026 updated by: Peerbridge Health, Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Recruiting
        • Orange County Heart Institute
        • Principal Investigator:
          • Brian Kolski, MD
        • Contact:
      • Pasadena, California, United States, 91107
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sachin Parikh, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Sameer Jamal, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • David Landers, MD
        • Sub-Investigator:
          • Mody Kanika, MD
    • New York
      • New York, New York, United States, 10019
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
    • Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants will be recruited from the community population receiving treatments or affiliated with participating trial sites. These sites will include hospitals, cardiac/medical/academic research centers, and medical practice clinics. It is anticipated that 6 to 15 trial sites distributed across the United States will participate in the study.

Enrollment will aim to include participants across all four ASE Ejection Fraction Severity Categories to ensure sufficient statistical power for accuracy assessment. The study population will comprise both male and female participants, as ASE Ejection Fraction Severity category thresholds differ by gender.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort Breakdown to Power Accuracy Assessments

The study will enroll up to 2000 participants across Subprotocol A and B, with a predictive total cohort of at least 660 unique participants. Each participant must provide at least one valid paired data point, defined as ECHO results paired with at least 30 minutes of Peerbridge COR™ ECG data, acquired concurrently or within 3 hours of ECHO completion. Enrollment will occur at a minimum of 3 trial sites, with data collection ensuring at least 165 valid paired points per EF Severity category, as determined by the reference ECHO, from different participants.

A paired data point is considered invalid if all 5-minute sitting windows during a 15-minute session yield "Not Analyzable" outputs. Participants who do not comply with the protocol or do not yield valid paired data points will be excluded from analysis and study statistics. Trial site investigators may use institutional EMR databases to identify, qualify, and recruit participants from their community patient populations.
Device: 15-minutes of sitting during COR ECG Acquistion

Participants will follow a standardized protocol during a 15-minute seated session using the Peerbridge COR™ device. Participants will sit comfortably in an upright chair with a straight back; armrests are optional. Their feet must remain flat on the floor with legs uncrossed to ensure unobstructed blood flow and a stable posture. Arms should be relaxed and placed in their lap, on a flat surface (e.g., table), or on the armrest, ensuring they are not tensed or elevated. Participants will maintain a straight back with relaxed shoulders throughout the session.

To begin, participants will press the Event Button on the Peerbridge COR™ mobile device, marking the start of the session. They will remain seated in this position for 15 minutes. At the end of the session, participants will press the Event Button again to mark the conclusion of the seated event. This protocol ensures consistent data collection across all participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of CorEFS Software EF Severity Categories Using Peerbridge COR™ ECG Data with ASE EF Severity Categories Established by Ultrasound Echocardiography
Time Frame: Through study completion, average of 9 months.
The primary endpoint of this trial is to demonstrate substantial agreement between EF severity categories determined by the CorEFS Software using 5 minutes of Peerbridge COR™ ECG data and the subject's EF severity category established through ultrasound echocardiography, the gold standard for EF classification. The study includes four co-primary endpoints, representing agreement measures within each of the four EF severity categories defined by the American Society of Echocardiography (ASE) Scale (Normal, Mildly Abnormal, Moderately Abnormal, Severely Abnormal). For each category the endpoint is the proportion of participants correctly classified by the test device relative to the reference standard. The goal is to demonstrate at least 80% agreement within each EF severity category.
Through study completion, average of 9 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Confirmation of ≥80% Agreement Between Peerbridge Cor™ ECG Data and Reference Standard ECHO in EF Severity Categorization Using 15-Minute Continuous Monitoring: Secondary Endpoint Analysis
Time Frame: Through study completion, average of 9 months.
The secondary endpoint is to confirm at least 80% agreement between the proportion of all participants, correctly categorized in all 4 EF Severity Categories by analyzing 15-minutes of continuous Peerbridge Cor™ ECG device data compared to those that are categorized by the Reference Standard ECHO. This will be tested with a one-sided single-sample z-test at a 97.5% confidence level to see if agreement exceeds 80%, thereby rejecting the null hypothesis of ≤80% agreement in favor of significant concordance.
Through study completion, average of 9 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Substantial Equivalence of Peerbridge Cor™ ECG-Derived EF Severity Results Across 2-Minute, 5-Minute, and 15-Minute Time Windows Compared to Reference Standard ECHO
Time Frame: Through study completion, average of 9 months.
Analysis will be conducted to assess for statistical agreement between the proportion of all subjects, correctly categorized in all 4 EF Severity Categories by analyzing 2-minutes of continuous Peerbridge Cor™ ECG device data compared to those that are categorized by the Reference Standard ECHO. This will be tested with a one-sided single-sample z-test at a 97.5% confidence level to see if agreement exceeds 80%, thereby rejecting the null hypothesis of ≤80% agreement in favor of significant concordance.
Through study completion, average of 9 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peerbridge Health, Inc

Investigators

  • Principal Investigator: Sameer Jamal, MD, Hackensack Meridian Health
  • Principal Investigator: Andrea Natale, MD, Texas Cardiac Arrhythmia Research Foundation
  • Principal Investigator: Johanna P Contreras, MD, Mount Sinai Hospital
  • Principal Investigator: Sachin Parikh, MD, Henry Ford Hospital
  • Principal Investigator: Brian Kolski, MD, Orange County Heart Institute
  • Principal Investigator: Daniel Bensimhon, MD, Moses H. Cone Memorial Hospital
  • Principal Investigator: Sandeep Gulati, PhD, Peerbridge Health, Inc
  • Principal Investigator: Frank Mazzola, MD, South Heart Clinic
  • Principal Investigator: Andrea Natale, MD, HCA Los Robles Hospital & Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBH-COREFS-1-A (Other Identifier: Peerbridge Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-Identified Case Report Forms; Peerbridge COR ECG Waveform Data in standards representation (MIT-BIH Physionet Format); 12-Lead ECG PDF and DICOM files; and ECHO Reports. Adverse Event Information.

IPD Sharing Time Frame

60 days after Trial Scoring is Completed. Expected Around December 2026. Will be available for 3 years after the date.

IPD Sharing Access Criteria

Trial Site PI, Sub-Investigators, Trial Site Research Staff, Trial Site Affiliates, Data Safety Monitoring Board (DSMB)Members, KOLs invited to Data Reviews and Affiliates; Publication submissions sites if required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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