Cor360: Clinician-Facing Broad-Spectrum Cardiac Phenotyping and Risk Assessment Using COR® Wearable ECG to Inform Outcomes-Oriented Care Pathways

Summary

Cor360 is an observational study evaluating whether extended wearable electrocardiogram (ECG) data can support broad-spectrum cardiac phenotyping and risk assessment beyond conventional single-purpose ambulatory rhythm monitoring. The study evaluates a clinician-facing, AI-enabled decision-support system that analyzes data from the Cor XT and Cor MDx wearable ECG devices and organizes patient-specific findings into an integrated Cor360 report for review by qualified clinicians.

Rather than focusing only on detection of arrhythmias, Cor360 evaluates multiple dimensions of cardiovascular physiology and disease simultaneously. The active Cor360 indication panel may include more than 150 reportable findings or sub-findings organized across six clinically oriented pathways: Structural, Functional, Conductance, Hemodynamic, Neurohormonal/Autonomic, and Atrial Fibrillation/Ventricular Arrhythmia/Sudden Cardiac Death.

Depending on the ECG data available for an individual participant, Cor360 may characterize findings and risk markers related to left ventricular hypertrophy and atrial enlargement; heart-failure phenotype and ejection-fraction-related abnormalities; conduction delay and heart block; repolarization and ischemia-related abnormalities; atrial fibrillation and atrial substrate; ventricular ectopy, nonsustained ventricular tachycardia and electrical-instability markers; syncope mechanisms; and selected ECG-derived hemodynamic and structural/functional surrogates. The platform may also evaluate autonomic regulation and heart-rate variability, cardiopulmonary coupling, sleep-disordered breathing and obstructive sleep apnea screening indicators, electrolyte-related ECG abnormalities, and other clinically relevant physiologic patterns.

Cor360 is designed to move from isolated ECG findings toward multidimensional cardiac phenotyping and multi-pathway risk assessment. Individual findings may be combined into clinically meaningful phenotypes and risk profiles, such as atrial-fibrillation-prone substrate, heart-failure-related autonomic or repolarization profiles, ventricular electrical-instability patterns, ischemia-related risk signals, or sleep-disordered-breathing-related cardiovascular burden. Where repeated ECG studies are available, Cor360 may also assess changes in cardiac phenotype, physiologic state, and risk trajectory over time.

Reports are individualized rather than identical across participants. Only indications supported by the participant's available data, signal quality, monitoring duration, and applicable analysis criteria are presented. Longer-duration recordings may support deeper assessment of autonomic function, sleep-related physiology, intermittent abnormalities, and longitudinal risk patterns.

Cor360 also evaluates whether an extended wearable ECG record can support cross-domain clinical synthesis rather than requiring each physiologic signal to be interpreted in isolation. When appropriate, reports may link detected phenotypes and risk markers to guideline-informed care-pathway considerations while identifying uncertainty, data-quality limitations, and findings that are not reportable because monitoring-duration or signal criteria are not met.

The primary objective of the study is to determine whether clinicians judge Cor360 reports to provide clinically actionable cardiac phenotyping or risk-assessment information. The study will also evaluate whether reviewing a Cor360 report changes, refines, or confirms a clinician's assessment or intended care pathway, and how Cor360 findings agree with available clinical reference information, standard-of-care testing, or independent expert review.

The study includes adults 18 years of age or older with completed or planned Cor XT or Cor MDx wearable ECG monitoring. It includes retrospective and prospective single-study assessments, longitudinal repeated-study assessments, combined retrospective/prospective analyses, and selected limited-duration streaming or patient-activated event assessments.

The protocol spans real-world acquisition settings, including home, clinic, ambulatory care, emergency department/triage, ambulance or transport, hospital-based, and hybrid clinic-to-home workflows. Where suitable reference information is available, Cor360 findings may be compared with 12-lead ECG interpretation, Holter or ambulatory ECG findings, echocardiography, other imaging, laboratory results, sleep testing, clinical diagnosis, or blinded expert-panel review.

Cor360 is being evaluated as a clinician-facing decision aid and not as an autonomous diagnostic system. Its outputs are intended to augment clinical interpretation and support consideration of relevant care pathways, including rhythm management, heart-failure evaluation, ischemia assessment, conduction or pacing evaluation, and sleep-apnea work-up. The clinician remains responsible for diagnosis, treatment, testing, referral, and patient management.

Conditions

• Cardiovascular Diseases
• Cardiovascular Diseases Risk
• Cardiac Conduction System Disease
• Bundle/Fascicular Abnormalities
• His-Purkinje Disease
• Arrhythmias, Cardiac
• Rhythm Phenotypes
• Myocardial Ischemia
• Syncope
• Syncope Recurrent
• Syncope and Collapse
• Seizure Disorder
• Sleep Apnea Syndrome, Obstructive
• Decision Support Systems, Clinical
• Heart Failure - NYHA II - IV
• Heart Failure (for Example, Fluid Overload)
• HRV
• Cardiopulmonary
• Sudden Cardiac Arrest
• Cardiac Arrest (CA)
• Ventricular Arrhythmias and Cardiac Arrest
• Ventricular Fibrillation
• QT Dispersion
• Atrial Cardiomyopathy

Interventions

DEVICE

COR Wearable ECG Monitoring

Extended ambulatory ECG data obtained using the Cor XT or Cor MDx wearable ECG platform. Eligible recordings may include previously completed or prospectively acquired single-study, longitudinal, streaming-telemetry, or patient-activated-event data, depending on the applicable Cor360 subprotocol.

OTHER

Cor360 Clinician-Facing Decision-Aid Reporting

Clinician-facing Cor360 analysis of eligible COR wearable ECG data to generate structured multidomain cardiac phenotyping, risk-assessment, and care-pathway information for review by qualified clinicians. Cor360 is evaluated as a decision aid and does not autonomously direct diagnosis, treatment, triage, or patient management.

Sponsors & Collaborators

• Peerbridge Health, Inc

  lead INDUSTRY

Principal Investigators

• Sandeep Gulati, PhD · Peerbridge Health, Inc

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-08-20

Primary Completion

2028-10-31

Completion

2030-06-17

FDA Device

Yes

Countries

• United States

Study Locations