An observational study in Ventricular Ejection Fraction, LVF and LV Dysfunction, sponsored by Peerbridge Health, Inc. Recruiting at 8 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Peerbridge Health, Inc · Observational
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.
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.
260 studies on the registry are indexed under Ventricular Dysfunction, Left; 57 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 198 across 103 observational studies indexed under Ventricular Dysfunction, Left.
Browse Ventricular Dysfunction, Left studies →Peerbridge Health, Inc is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
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.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 60 days after Trial Scoring is Completed. Expected Around December 2026. Will be available for 3 years after the date.
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.
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