Cor360NCT07775976

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

StatusEnrolling by Invitation

PhaseNot specified

SponsorPeerbridge Health, Inc

Primary completionOct 31, 2028 (estimated)

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Record History

All 2 versions: 2 with changes below.

Notable Aug 20, 2026 Enrolling by invitation only
- Start date changed from estimate of Oct 15, 2026 to Aug 20, 2026
- Site contacts updated at 2 of 2 sites
v2
Aug 17, 2026 Study First Submitted

Notable: the plan changed

Endpoints

Primary

Clinician-Confirmed Actionability of Cor360 Reports

Timeframe: At clinician review of each Cor360 report; outcomes aggregated through study completion, up to 48 months.

Secondary (2)

Impact of Cor360 on Clinician Assessment and Intended Care Pathway

Concordance of Cor360 Findings With Clinical Reference Information or Independent Expert Review

Arms and interventions

Cor360 Observational Cohort

Adults with eligible Cor XT or Cor MDx wearable ECG data evaluated using the Cor360 clinician-facing cardiac phenotyping and risk-assessment framework. Participants may contribute single or serial ECG studies through retrospective, prospective, longitudinal, ambidirectional, streaming-telemetry, or patient-activated-event workflows. Cor360 evaluates multidomain cardiovascular information spanning rhythm, conduction, repolarization, structural/functional, autonomic, cardiopulmonary, sleep-related, and longitudinal phenotypes, with all outputs reviewed by qualified clinicians in clinical context.

Devices: COR Wearable ECG Monitoring

Other: Cor360 Clinician-Facing Decision-Aid Reporting

Sites

2 sites in 1 country

About this trial

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.

Trial details

Enrollment: 1,000 participants (estimated)
Started: Aug 20, 2026
Study completion: Jun 17, 2030 (estimated)
Eligibility: 18 and older, all sexes, healthy volunteers accepted
Design: Observational
Oversight: Data monitoring committee, FDA-regulated device
Conditions: Arrhythmias, Cardiac, Cardiac Conduction System Disease, Cardiovascular Diseases, Death, Sudden, Cardiac, Edema, Epilepsy, Heart Arrest, Heart Failure +23 more
First posted: Aug 20, 2026
Registry updated: Aug 21, 2026
Last verified: Aug 2026

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