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

NCT07775976 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: PBH-COR-360-1-A
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cor360; COR 360; Cardiac phenotyping; Cardiovascular risk assessment; Ambulatory electrocardiography; Longitudinal cardiac monitoring; LTM; RPM; Autonomic dysfunction; Cardiopulmonary coupling; ECG-derived biomarkers; Multidomain cardiovascular assessment; Sudden cardiac death risk; Heart failure phenotyping; Ventricular arrhythmia; Artificial intelligence; Cardiac conduction disease

Outcome Measures

Primary Outcomes (1)

• Clinician-Confirmed Actionability of Cor360 Reports

  Proportion of clinician-reviewed evaluable Cor360 reports classified as clinically actionable on a pre-specified structured clinician review form. A report is actionable when the clinician documents that Cor360 contributed to identification, confirmation, or refinement of a clinically relevant phenotype or risk assessment; selection or modification of a care pathway; clinically meaningful triage or follow-up; an informative no-action determination; or identification of uncertainty or limitations requiring further review. Mere acknowledgment or filing does not qualify. The actionable proportion is reported with a two-sided 95% CI. The endpoint is met if the lower bound of the 95% CI exceeds 60% and at least 80% of a pre-specified random subsample of actionable determinations have an adequately documented clinical basis on independent blinded verification.

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

Secondary Outcomes (2)

• Impact of Cor360 on Clinician Assessment and Intended Care Pathway

  Immediately before and after clinician review of each applicable Cor360 report; outcomes aggregated through study completion, up to 48 months.

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

  For each reference-available study, following Cor360 output lock and reference adjudication; reference assessment completed within 30 days of the corresponding analysis, with outcomes aggregated through study completion, up to 48 months.

Other Outcomes (2)

• Independent Verification of Clinician-Reported Actionability

  Following clinician review of sampled actionable reports; aggregated through study completion, up to 48 months.

• Longitudinal Change in Cor360 Cardiac Phenotypes and Risk Markers

  Across serial COR studies, up to 50 reportable visits or episodes per participant and through study completion, up to 48 months.

Study Arms (1)

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.

Device: COR Wearable ECG Monitoring; Other: Cor360 Clinician-Facing Decision-Aid Reporting

Interventions

COR Wearable ECG Monitoring DEVICE

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.

Also known as: COR Wearable ECG Monitoring (Cor XT and Cor MDx)

Cor360 Observational Cohort

Cor360 Clinician-Facing Decision-Aid Reporting OTHER

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.

Cor360 Observational Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18 years or older with completed or planned Cor XT or Cor MDx wearable ECG monitoring whose data are eligible for Cor360 processing. The population may include individuals with known or suspected cardiovascular or cardiopulmonary disease, symptomatic or higher-risk patients, post-acute or post-procedural populations, and healthy asymptomatic individuals, including athletes, where permitted by the applicable subprotocol. Eligible data may derive from retrospective, prospective, longitudinal, ambidirectional, streaming-telemetry, or patient-activated-event workflows across home, ambulatory, outpatient, hospital, emergency, triage, or transport settings. Licensed healthcare professionals who complete required Cor360 training and attestation participate as clinician reviewers.

You may qualify if:

• Age 18 years or older at the time of Cor XT or Cor MDx wearable ECG monitoring.
• Completed or planned Cor XT or Cor MDx wearable ECG monitoring with sufficient raw data and metadata for Cor360 processing.
• Availability of required study identifiers, monitoring duration, device type, and data-quality metadata.
• Monitoring may occur in approved home, clinic, ambulatory, hospital/triage, emergency-care, ambulance, transport, or clinic-to-home settings as permitted by the applicable subprotocol, IRB approval, consent/authorization pathway, site workflow, and device-use controls.
• For prospective participation, ability and willingness to comply with applicable consent and monitoring procedures unless an IRB-approved alternative applies.
• For Subprotocol E, at least one eligible historical COR study and at least one planned prospective COR study, with authorization permitting linked historical and prospective analysis.

You may not qualify if:

• Insufficient or corrupted Cor XT or Cor MDx wearable ECG data that precludes meaningful Cor360 report generation.
• Missing authorization, informed consent, waiver, or data-use permission required for analysis.
• Data-provenance uncertainty that prevents linkage to the correct subject or study record.
• Any condition or circumstance that, in the investigator's judgment, makes study-data use inappropriate or unsafe.
• Active professional license in an applicable jurisdiction and practice within professional scope.
• Training or clinical role relevant to cardiology, electrophysiology, internal medicine, family medicine, pulmonology, sleep medicine, emergency medicine, advanced-practice cardiology, or related care pathways.
• Completion of Cor360 training and clinician attestation before report access.
• Agreement to use Cor360 reports only under protocol-defined conditions and to report discrepancies or safety concerns.
• Inactive, restricted, or suspended clinical license.
• Failure to complete required Cor360 training or attestation.
• Failure to comply with confidentiality, privacy, or protocol obligations.
• Investigator or Sponsor determination that continued participation is inappropriate.

Sponsors & Collaborators

• Peerbridge Health, Inc: lead

Study Sites (2)

Peerbridge Health, Inc.

Pasadena, California, 91107, United States

Location

Peerbridge Health, Inc.

Nashville, Tennessee, 37076, United States

Location

Related Publications (5)

• Attia ZI, Harmon DM, Dugan J, Manka L, Lopez-Jimenez F, Lerman A, Siontis KC, Noseworthy PA, Yao X, Klavetter EW, Halamka JD, Asirvatham SJ, Khan R, Carter RE, Leibovich BC, Friedman PA. Prospective evaluation of smartwatch-enabled detection of left ventricular dysfunction. Nat Med. 2022 Dec;28(12):2497-2503. doi: 10.1038/s41591-022-02053-1. Epub 2022 Nov 14.

  PMID: 36376461 BACKGROUND

• Attia ZI, Kapa S, Lopez-Jimenez F, McKie PM, Ladewig DJ, Satam G, Pellikka PA, Enriquez-Sarano M, Noseworthy PA, Munger TM, Asirvatham SJ, Scott CG, Carter RE, Friedman PA. Screening for cardiac contractile dysfunction using an artificial intelligence-enabled electrocardiogram. Nat Med. 2019 Jan;25(1):70-74. doi: 10.1038/s41591-018-0240-2. Epub 2019 Jan 7.

  PMID: 30617318 BACKGROUND

• Hannun AY, Rajpurkar P, Haghpanahi M, Tison GH, Bourn C, Turakhia MP, Ng AY. Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nat Med. 2019 Jan;25(1):65-69. doi: 10.1038/s41591-018-0268-3. Epub 2019 Jan 7.

  PMID: 30617320 BACKGROUND

• Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155. doi: 10.1001/jama.2018.8102.

  PMID: 29998336 BACKGROUND

• Barrett PM, Komatireddy R, Haaser S, Topol S, Sheard J, Encinas J, Fought AJ, Topol EJ. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am J Med. 2014 Jan;127(1):95.e11-7. doi: 10.1016/j.amjmed.2013.10.003. Epub 2013 Oct 15.

  PMID: 24384108 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Cardiac Conduction System Disease; Arrhythmias, Cardiac; Myocardial Ischemia; Syncope; Epilepsy; Sleep Apnea, Obstructive; Heart Failure; Edema; Death, Sudden, Cardiac; Heart Arrest; Ventricular Fibrillation; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Death, Sudden; Death; Autonomic Nervous System Diseases

Study Officials

• Sandeep Gulati, PhD

  Peerbridge Health, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): June 17, 2030
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: De-identified IPD and applicable supporting information may be made available after completion of the relevant analyses and publication of the principal study results. Requests may be considered following database lock and publication, subject to completion of applicable regulatory, privacy, contractual, and Sponsor review requirements. Availability will continue for a period consistent with Sponsor record-retention requirements and the approved purpose of the data-sharing request.
• Access Criteria: De-identified IPD and selected supporting documents may be provided to qualified researchers whose proposed use is scientifically appropriate and consistent with the study consent, IRB approvals or waivers, applicable privacy requirements, and Sponsor policies. Access will require Sponsor review and, where applicable, an executed data-use agreement specifying the approved research purpose, permitted analyses, confidentiality and security requirements, prohibition on re-identification, and limits on onward disclosure. Only data necessary for the approved research question will be provided. Direct identifiers and linkage keys will not be shared unless specifically authorized by the IRB, consent/HIPAA authorization, and applicable law.

Locations

US (2)