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

ConditionsVentricular Ejection FractionLVFLV DysfunctionAtrial EnlargementConduction DefectHeart FailureValvular Heart DiseaseIschemic Heart DiseaseCardiotoxicityMyocardial InfarctionDilated CardiomyopathyHFrEF - Heart Failure With Reduced Ejection FractionHFpEF - Heart Failure With Preserved Ejection FractionSyncopeRemodeling, Cardiac
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeerbridge Health, Inc

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years

Able and eligible to wear a Holter monitor

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 15-minutes of sitting during COR ECG Acquistion

    Device

    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.

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Cohort Breakdown to Power Accuracy Assessments1 intervention

Trial outcomes

Primary outcomes

1

Agreement of CorEFS Software EF Severity Categories Using Peerbridge COR™ ECG Data with ASE EF Severity Categories Established by Ultrasound Echocardiography

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.

Time frame
Through study completion, average of 9 months.

Secondary outcomes

1

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

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.

Time frame
Through study completion, average of 9 months.

Other outcomes

1

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

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.

Time frame
Through study completion, average of 9 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peerbridge Health, Inc

Lead sponsor

Source ClinicalTrials.gov
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