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.
Cor360 is designed to evaluate whether extended wearable electrocardiography can provide a broader view of cardiovascular physiology and risk than conventional ambulatory ECG analysis focused primarily on rhythm and arrhythmia detection. The study evaluates a clinician-facing analytical and reporting framework that transforms COR wearable ECG recordings into structured, patient-specific cardiac phenotyping and risk-assessment information. Cor360 is intended to help qualified clinicians interpret multiple dimensions of cardiovascular physiology from a common ECG record and place applicable findings into clinically recognizable care pathways. The conceptual basis is that extended ECG contains information at several physiologic scales. In addition to rhythm, rate, ectopy, pauses, and conventional conduction abnormalities, the recording may contain patterns related to atrial and ventricular electrical substrate, conduction and repolarization, ischemia-associated ST-T behavior, ventricular electrical instability, autonomic regulation, heart-rate variability, cardiopulmonary interaction, sleep-related physiology, and ECG-derived structural, functional, or hemodynamic surrogates. Cor360 therefore evaluates broad-spectrum monitoring rather than single-endpoint detection, cardiac phenotyping rather than isolated labels, multi-pathway risk assessment rather than a single risk score, and pathway-aware clinician decision support rather than stand-alone alerts. MULTIDOMAIN CARDIAC PHENOTYPING Cor360 organizes applicable findings into six clinically oriented pathways: Structural, Functional, Conductance, Hemodynamic, Neurohormonal/Autonomic, and Atrial Fibrillation/Ventricular Arrhythmia/Sudden Cardiac Death. The active indication framework may include more than 150 findings or sub-findings. Only findings applicable to the individual subject and adequately supported by the available data are carried forward into the clinician-facing report. Representative structural and functional assessments may include left ventricular hypertrophy, left or right atrial enlargement, heart-failure-related phenotypes, ejection-fraction-related abnormalities, HFrEF/HFpEF phenotype indicators, myocardial scar or prior-infarct-associated patterns, ventricular remodeling, ventricular activation abnormalities, and other appropriately qualified ECG-derived structural or functional surrogates. Conductance assessment may include atrioventricular conduction abnormalities, bundle branch or fascicular abnormalities, intraventricular conduction delay, electrical dyssynchrony, ventricular activation timing, atrial conduction heterogeneity, and findings potentially relevant to His-Purkinje disease or pacing evaluation. Repolarization and ischemia-related assessment may include QT/QTc behavior, QT dispersion, T-wave abnormalities, T-wave alternans, dynamic ST-T changes, ST elevation or depression trends, pathologic Q-wave indicators, myocardial-ischemia-related screening markers, and patterns suggestive of altered repolarization reserve or electrical instability. Rhythm and arrhythmic-risk assessment may extend beyond AF detection to include atrial flutter, supraventricular tachycardia, ventricular premature complexes, ventricular ectopy burden, nonsustained ventricular tachycardia, bradyarrhythmia, pauses, tachy-brady patterns, AF burden, AF-related substrate and risk markers, and patterns associated with ventricular arrhythmia or sudden-cardiac-death susceptibility. For atrial fibrillation, Cor360 may assess substrate even when sustained AF is not captured during the observation window. Atrial enlargement surrogates, P-wave morphology or dispersion, PR prolongation, autonomic behavior, and related structural features may provide context regarding AF susceptibility. Similarly, ventricular risk assessment is not limited to ectopy counts. Ventricular ectopy, NSVT, repolarization abnormalities, QT behavior, T-wave alternans, conduction disease, myocardial scar-related patterns, heart-failure-related surrogates, and autonomic findings may provide complementary information regarding ventricular electrical instability. AUTONOMIC, HEART-RATE-VARIABILITY, CARDIOPULMONARY, AND SLEEP ASSESSMENT Extended monitoring permits characterization of autonomic physiology over hours, days, sleep periods, activity transitions, and repeated studies rather than from a short ECG segment. Cor360 may evaluate time-domain HRV measures such as SDNN, RMSSD, pNN50, and HRV triangular index; frequency-domain measures including ultra-low-frequency, low-frequency, and high-frequency power and LF/HF relationships; and nonlinear measures such as SD1 and SD2 when data sufficiency is adequate. These measures may be organized into physiologic descriptions of autonomic regulation, vagal modulation, sympathovagal balance, circadian regulation, recovery efficiency, autonomic reserve, autonomic drift, and cumulative autonomic burden. Longitudinal analyses may characterize changes relative to a subject's own baseline, including low-HRV burden, visit-to-visit variability, stress-reactivity patterns, recovery-efficiency patterns, sympathovagal imbalance, and complexity-reserve trajectory. These are physiologic autonomic outputs and are not intended to diagnose psychological or behavioral-health conditions. Cardiopulmonary assessment may include respiratory sinus arrhythmia, cardiopulmonary coupling, nocturnal heart-rate behavior, and selected ECG-derived hemodynamic estimates or surrogates when supported by the applicable data. When sufficient overnight information is available, Cor360 may also evaluate sleep-disordered-breathing-related patterns, estimated apnea/hypopnea or respiratory-disturbance burden, nocturnal autonomic responses, and associated cardiopulmonary patterns. Repeated nights may permit assessment of night-to-night variability. PATIENT-SPECIFIC AND INDICATION-ADAPTIVE REPORTING Cor360 reports are individualized. Two subjects monitored with the same device for similar durations may receive substantially different reports because different abnormalities, risk markers, and data-sufficiency conditions are present. Only applicable and adequately supported findings are surfaced. Domains requiring prolonged monitoring, sufficient beat counts, specific channel availability, sleep periods, acceptable signal quality, or longitudinal comparison are not inferred when those requirements are absent. The depth of reporting therefore scales with the information content of the recording. A short or artifact-limited dataset may support a narrow set of outputs. A high-quality multiday recording may support intermittent rhythm assessment, nocturnal physiology, autonomic behavior, and duration-dependent findings. Repeated studies may additionally support trajectory analysis. FROM INDIVIDUAL FINDINGS TO CLINICALLY MEANINGFUL PHENOTYPES A central question in Cor360 is whether combinations of ECG-derived observations can be organized into higher-level phenotypes that are more clinically meaningful than isolated algorithm outputs. A heart-failure-related phenotype may incorporate rhythm burden, ventricular activation and conduction, repolarization, autonomic behavior, and ECG-derived structural or functional markers. The purpose is not to replace imaging, but to determine whether wearable ECG-derived patterns contribute to clinical concern or further evaluation. An atrial phenotype may incorporate AF occurrence or burden together with atrial enlargement surrogates, P-wave morphology, P-wave dispersion, PR behavior, autonomic characteristics, and related structural or heart-failure markers. An electrical-instability phenotype may integrate ventricular ectopy, NSVT, QT and repolarization behavior, T-wave alternans, conduction abnormalities, myocardial scar-associated patterns, and heart-failure-related findings. A syncope-oriented assessment may distinguish patterns compatible with arrhythmic, bradyarrhythmic, conduction-related, tachy-brady, QT-mediated, supraventricular, reflex/vasovagal, orthostatic, or other physiologic mechanisms when supported by the extended recording and available clinical context. MULTI-PATHWAY CLINICAL VALUE The study evaluates whether Cor360 contributes to clinical reasoning across multiple care pathways rather than merely producing additional ECG measurements. Potential clinical value includes identification, confirmation, or refinement of a cardiac or cardiopulmonary phenotype; recognition that a finding deserves greater or lesser clinical priority; identification of an abnormality requiring confirmatory evaluation; modification of monitoring or follow-up strategy; referral; medication review; repeat testing; or a documented determination that no additional action is required at that time. A Cor360 finding may therefore be useful without directly establishing a diagnosis. Heart-failure-related ECG characteristics may support consideration of structural evaluation. Progressive conduction abnormalities may support conduction or pacing assessment. An atrial substrate profile may support closer rhythm surveillance. Sleep-related cardiopulmonary patterns may support sleep-apnea evaluation. Ischemia-related or repolarization patterns may support standard diagnostic assessment within the clinical context. Where appropriate, Cor360 may map findings to guideline-informed care pathways including rhythm management, heart-failure evaluation and imaging, ischemia evaluation, conduction or pacing assessment, sleep-apnea work-up, and longitudinal cardiovascular follow-up. SIX-SUBPROTOCOL STUDY ARCHITECTURE Time Perspective: Cor360 uses a mixed observational time perspective across its six subprotocols. Subprotocols A and B are retrospective; Subprotocols C and D are prospective; Subprotocol E is ambidirectional, linking previously acquired historical COR data with newly acquired prospective data from the same subject; and Subprotocol F evaluates prospectively acquired or approved near-real-time streaming and patient-activated event data. The protocol therefore includes retrospective, prospective, longitudinal, and linked historical-to-prospective observation rather than a single temporal design. The six-subprotocol structure evaluates Cor360 across different temporal perspectives, clinical workflows, and types of available data. The design progresses from analysis of one historical ECG study, through retrospective and prospective longitudinal assessment, to within-subject comparison of historical and newly acquired data, and finally to limited-duration streaming or patient-activated event assessment. Together, the subprotocols create a continuum from single-episode characterization to longitudinal cardiovascular phenotyping. SUBPROTOCOL A - RETROSPECTIVE SINGLE-STUDY ANALYSIS Subprotocol A evaluates one previously completed COR wearable ECG study. The recording is processed through Cor360 to generate a clinician-facing report based on the available data and authorized associated information. This allows evaluation across historical datasets and diverse clinical populations without new patient-device interaction. Subprotocol A can characterize the breadth of reportable domains obtainable from a single extended recording, identify data-quality and monitoring-duration requirements for different analyses, and evaluate whether clinicians consider the resulting phenotyping and risk-assessment information clinically meaningful. Where suitable independent clinical information exists, applicable findings may also be compared with conventional ambulatory ECG interpretation, 12-lead ECG, imaging, laboratory testing, sleep testing, clinical diagnosis, or independent expert review. SUBPROTOCOL B - RETROSPECTIVE LONGITUDINAL ANALYSIS Subprotocol B evaluates subjects with two or more previously completed COR studies that can be reliably linked to the same individual. Rather than treating each recording only as an independent episode, Cor360 may process the studies serially and evaluate change across time. Potential longitudinal variables include arrhythmia burden, atrial or ventricular substrate, conduction disease, repolarization behavior, autonomic measures, sleep-related patterns, structural or functional risk surrogates, reportability, and care-pathway-relevant signals. This design reflects the fact that cardiovascular disease may evolve gradually. A finding that is borderline on one recording may become more prominent on subsequent recordings, while abnormalities present before treatment or intervention may diminish during follow-up. Serial analysis can therefore characterize stability, progression, recovery, variability, or emergence of new phenotypes. Where interval clinical context is available, ECG changes may be interpreted relative to medications, procedures, therapy, hospitalization, symptom evolution, or other clinically meaningful events. The purpose is to evaluate whether prior wearable ECG studies can become part of a longitudinal physiologic record rather than remain isolated monitoring episodes. SUBPROTOCOL C - PROSPECTIVE SINGLE-STUDY ANALYSIS Subprotocol C evaluates a newly acquired COR wearable ECG study under an approved prospective workflow. The design permits evaluation of Cor360 across the complete sequence from acquisition through report generation and clinician interpretation and across real-world environments such as home, clinic, ambulatory care, clinic-to-home monitoring, and approved higher-acuity workflows. Where applicable, the clinician may document an assessment before the Cor360 report is revealed. After reviewing Cor360, the clinician documents whether the report changed, refined, or confirmed that assessment or intended care pathway. This sequence evaluates incremental decision-support value rather than simply whether a report contains potentially useful information. Potential areas of influence include overall cardiac risk, prioritization of a phenotype, rhythm assessment, heart-failure concern, ischemia or repolarization concern, conduction or structural concern, cardiopulmonary or sleep-related concern, additional diagnostic testing, referral, repeat monitoring, longitudinal follow-up, or clinician confidence in the planned care pathway. SUBPROTOCOL D - PROSPECTIVE LONGITUDINAL ANALYSIS Subprotocol D extends prospective assessment across repeated COR studies in the same subject. This permits evaluation of cardiovascular physiology as a trajectory. AF burden may emerge or change. Ventricular ectopy may increase or decrease. Conduction disease may progress. Repolarization characteristics may change with medication, physiology, or disease. Autonomic regulation may deteriorate during illness and recover during convalescence. Sleep-related cardiovascular burden may vary. Heart-failure-associated electrical phenotypes may evolve with clinical status or therapy. Repeated extended recordings provide a mechanism for observing these processes outside the limited windows of conventional clinic-based testing. Subprotocol D evaluates longitudinal phenotyping, risk trajectory, response-to-care signals, and report stability. Where interval information is available, changes may be interpreted in relation to medication adjustment, therapeutic intervention, procedure, hospitalization, recovery, or disease progression. The broader question is whether changes across one or more physiologic domains provide clinically meaningful information regarding the patient's evolving cardiovascular state. SUBPROTOCOL E - AMBIDIRECTIONAL ANALYSIS Subprotocol E is a linked within-subject historical-plus-prospective design. At least one eligible historical COR study is linked to at least one newly acquired prospective COR study from the same subject. The historical recording provides a patient-specific physiologic baseline, while the prospective recording provides follow-up after an interval during which clinical status or treatment may have changed. Historical and prospective time points are intentionally linked to support within-subject comparison. The clinical value is that each patient can serve, in part, as his or her own physiologic reference. Population thresholds may not capture clinically meaningful within-person change. A subject may remain within a conventional population reference range while experiencing substantial change from his or her prior rhythm burden, autonomic state, conduction pattern, repolarization characteristics, sleep-related physiology, or other phenotype. Conversely, a persistently abnormal finding may demonstrate stability rather than continued deterioration. Cor360 may generate separate historical and prospective reports and/or a linked summary describing interval change. Available events between recordings may be considered, including changes in symptoms, medications, therapy, procedures, diagnoses, or hospitalization. Interpretation also considers differences in device configuration, monitoring duration, acquisition setting, signal quality, algorithm/report version, and data sufficiency between time points. This approach supports trajectory-based cardiovascular assessment by asking not only what phenotype is present, but how the patient's phenotype has changed. SUBPROTOCOL F - STREAMING TELEMETRY AND PATIENT-ACTIVATED EVENT ANALYSIS Subprotocol F evaluates limited-duration streaming ECG telemetry or patient-activated event data under approved workflows. Streaming episodes may include several hours of ECG data and, where available, multiple ECG channels together with respiratory impedance or accelerometer information. Patient-activated events may consist of short recordings associated with a timestamp, symptom, or activation context. The scientific purpose differs from extended Holter analysis. A multiday recording can support intermittent-event assessment, sleep physiology, circadian behavior, long-duration HRV, burden estimates, and other temporal features. A short event or streaming episode cannot support all of these analyses. Subprotocol F therefore evaluates whether selected Cor360 capabilities remain useful when the data window is constrained and whether conclusions are appropriately limited when duration-dependent information is unavailable. Potential settings include evaluation of symptomatic episodes, transport-associated clinician review, emergency-department or triage support, and targeted follow-up. Outputs requiring extended monitoring, sleep periods, longitudinal history, or other unmet data requirements are not inferred from the limited-duration dataset. CLINICAL POPULATIONS AND CARE SETTINGS OF INTEREST The breadth of Cor360 is particularly relevant in populations for whom cardiovascular risk extends beyond intermittent arrhythmia detection. Patients with heart failure, cardiomyopathy, structural heart disease, or significant electrical disease may benefit from longitudinal assessment of rhythm burden, conduction, repolarization, autonomic status, and ECG-derived structural or functional risk markers. The study evaluates whether these multidomain findings contribute useful information regarding disease state, treatment response, or need for further evaluation. Patients with advanced or recently decompensated heart failure are of particular interest because transitions of care may involve dynamic changes in arrhythmia burden, autonomic regulation, repolarization, and related physiologic markers. Patients with pulmonary hypertension or pulmonary disorders with cardiac involvement may exhibit right-heart strain patterns, arrhythmias, autonomic changes, or cardiopulmonary abnormalities. Relevant populations may include chronic obstructive pulmonary disease, severe asthma, interstitial lung disease, post-acute respiratory distress syndrome, pulmonary embolism follow-up, and advanced cystic fibrosis where cardiovascular consequences are clinically relevant. POST-ACUTE AND POST-PROCEDURAL APPLICATIONS Post-procedural surveillance is an important use case because meaningful rhythm or conduction abnormalities may emerge after the immediate inpatient monitoring period. Following transcatheter aortic valve replacement, new bundle branch block or delayed higher-grade atrioventricular conduction abnormalities may emerge after the periprocedural window. Extended monitoring may provide additional information regarding delayed conduction disease and further pacing evaluation. Following surgical or transcatheter valve procedures, extended monitoring may identify post-operative AF, conduction abnormalities, ventricular ectopy, or evolving electrical findings. Following coronary artery bypass grafting, extended ambulatory ECG may characterize post-operative AF, ventricular ectopy, repolarization, or ischemia-associated trends during recovery. After catheter ablation for atrial fibrillation or ventricular tachycardia, repeated ambulatory monitoring may characterize residual or recurrent arrhythmia burden and provide a broader electrical phenotype during follow-up. Patients receiving durable or temporary mechanical circulatory support may have substantial ventricular-arrhythmia burden and complex electrical substrate. Cor360 can evaluate whether extended rhythm and electrical-instability phenotyping provides useful complementary information. CARDIAC SAFETY AND CARDIO-ONCOLOGY Cor360 may also be evaluated in populations receiving therapies associated with cardiovascular toxicity. Patients receiving potentially cardiotoxic therapies may require surveillance for arrhythmia, conduction abnormalities, QT/QTc changes, and evolving evidence of ventricular dysfunction. Serial wearable ECG phenotyping may provide complementary information between conventional imaging or biomarker assessments, particularly where cardiovascular effects may emerge over time. Participants in therapeutic trials with cardiac-safety requirements may similarly benefit from extended assessment of rhythm, conduction, and repolarization as a complement to protocol-defined 12-lead ECG and other dedicated cardiac-safety evaluations. VENTRICULAR-ARRHYTHMIA AND SUDDEN-CARDIAC-DEATH RISK Another area of interest is the patient with a combination of risk factors rather than a single high-risk marker. Examples may include NSVT, high ventricular-ectopy burden, prior myocardial infarction or scar-associated ECG patterns, QT or repolarization abnormalities, conduction disease, autonomic abnormalities, or ECG-derived surrogates associated with ventricular dysfunction. Cor360 evaluates whether integration of these observations can provide a clinically interpretable ventricular-risk phenotype that helps identify individuals for whom additional evaluation may be appropriate. SYNCOPE AND MECHANISM-ORIENTED ASSESSMENT Syncope illustrates another limitation of purely event-counting ECG analysis. The clinical question is often not simply whether an arrhythmia occurred but whether the observed physiologic pattern is compatible with an arrhythmic, bradyarrhythmic, conduction-related, reflex, orthostatic, tachy-brady, QT-mediated, supraventricular, structural, or other mechanism. Extended recordings may provide combinations of rhythm, heart-rate dynamics, conduction behavior, pauses, autonomic measures, and symptom-associated events that contribute to this differential assessment. Cor360 evaluates whether organizing this information into a mechanism-oriented clinician-facing presentation supports interpretation and appropriate confirmatory evaluation. EMERGING AND DECENTRALIZED CARE SETTINGS The six-subprotocol design permits evaluation beyond the conventional model in which a patient receives a patch in a clinic and returns it several days later. Hospital-at-home programs, post-discharge monitoring, decentralized care, clinic-to-home monitoring, interfacility transport, emergency-department triage, and other hybrid workflows increasingly move cardiovascular observation outside traditional telemetry environments. These settings create a need for portable physiologic information that can remain interpretable across transitions in care. Cor360 can therefore be evaluated according to acquisition setting, monitoring duration, data quality, report completeness, and clinician usability. Higher-acuity applications remain clinician-facing decision-support workflows and do not replace real-time telemetry, emergency evaluation, 12-lead ECG, laboratory testing, imaging, bedside assessment, or clinician-directed triage and disposition. CLINICIAN-IN-THE-LOOP ASSESSMENT Cor360 is evaluated as a clinician-facing decision aid rather than as an autonomous diagnostic system. The study examines whether the information is meaningful when interpreted by a qualified clinician in the context of available clinical information. A report may provide clinical value when it contributes to identification or refinement of a phenotype, alters prioritization or urgency, supports additional diagnostic testing or referral, influences repeat-monitoring or follow-up strategy, contributes to medication review or care-pathway consideration, identifies uncertainty requiring confirmation, or supports a clinically justified determination that no additional action is indicated. A report is not considered useful merely because it was viewed or added to the record. The clinician must identify the finding, limitation, phenotype, risk marker, or care-pathway consideration that contributed to the assessment. ANALYTIC AND EVIDENTIARY RIGOR Because Cor360 evaluates a broad and evolving set of ECG-derived phenotypes and risk markers, the protocol distinguishes exploratory signal discovery from evidence intended to support more formal performance assessment. Each reportable output is assigned a pre-specified evidence status. Depending on the available validation, reference standard, data sufficiency, and intended use, an output may be classified as Confirmatory, Supportive, Exploratory, Demonstrative, or Not Reportable. This structure allows mature and investigational findings to coexist within the broad Cor360 framework without implying the same level of evidence for every output. For evaluable confirmatory analyses, the analytic configuration is prospectively controlled. The applicable algorithm/model version, preprocessing and feature-extraction methods, model weights, indication panel, thresholds, confidence-score method, report template, and output-labeling rules are locked and documented. Results generated under materially different analytic or report versions are not assumed to be interchangeable or pooled for confirmatory interpretation unless that approach is prospectively specified and justified. The protocol also separates information used to generate a Cor360 output from information used to judge that output. Where an independent clinical reference is available, concordance may be evaluated against sources such as 12-lead ECG, conventional ambulatory ECG, echocardiography, cardiac imaging, laboratory testing, sleep testing, clinical diagnosis, adjudicated chart review, or expert assessment. Reference adjudication is performed under a predefined process by reviewers blinded to the Cor360 result. Importantly, clinical information used as an input to generate a Cor360 phenotype cannot simultaneously serve as an independent blinded reference for that same output in a confirmatory concordance analysis. If such dependency exists, it is identified and the analysis is treated as supportive or exploratory rather than independent confirmatory evidence. This control is intended to reduce information leakage and circular validation. The clinician-actionability assessment incorporates a parallel safeguard. Clinician review alone is not sufficient to establish that a report was actionable. The clinician must document the specific phenotype, risk marker, limitation, or care-pathway consideration that contributed to the determination. A pre-specified random subset of reports classified as actionable undergoes independent blinded verification against the documented clinical basis. Where the locked pre-report/post-report procedure is used, the clinician's assessment before Cor360 exposure cannot subsequently be edited. This permits the study to distinguish information already known to the clinician from the incremental contribution of the Cor360 report. Where an independent reference is also available, the direction of a report-associated change can be examined relative to that reference, allowing distinction between changes toward versus away from the independently supported clinical assessment. Together, these controls allow Cor360 to evaluate a large multidomain indication framework while preserving traceability between the underlying data, analytic version, report content, clinician interpretation, and independent clinical evidence. PRE-REPORT/POST-REPORT DECISION ASSESSMENT Where workflow permits, the clinician's assessment is documented before Cor360 is revealed. The clinician first records an assessment based on available clinical and conventional study information. After reviewing Cor360, the clinician provides a second assessment. This permits evaluation of whether Cor360 changed, refined, or confirmed the clinician's assessment or intended care pathway. Potential areas of change include cardiac risk, urgency of follow-up, prioritized phenotype, rhythm assessment, heart-failure or ejection-fraction-related concern, ischemia or repolarization concern, conduction or structural concern, sleep-disordered-breathing or cardiopulmonary concern, additional testing, referral, repeat monitoring, longitudinal follow-up, and clinician confidence. REFERENCE-BASED CLINICAL CHARACTERIZATION Where suitable independent information is available, individual Cor360 findings may be compared with relevant clinical references. Depending on the indication, these may include conventional Holter or ambulatory ECG interpretation, 12-lead ECG, echocardiography, magnetic resonance or computed-tomographic imaging, laboratory testing, sleep testing, established clinical diagnosis, adjudicated chart review, or independent expert assessment. The appropriate comparator depends on the physiologic construct being evaluated. Rhythm findings may be compared with adjudicated ECG data; ejection-fraction-related outputs with cardiac imaging; electrolyte-associated ECG phenotypes with laboratory information; and sleep-disordered-breathing-related findings with applicable sleep testing. LONGITUDINAL TRAJECTORY AS CLINICAL INFORMATION A differentiating feature of Cor360 is its treatment of time as clinically meaningful information. A conventional ECG asks what is present at a particular moment. Extended monitoring asks what occurs over hours or days. Repeated extended monitoring adds a third question: how is the patient's physiology changing? The longitudinal and ambidirectional subprotocols are designed around this question. Changes in AF burden, ventricular ectopy, conduction, QT behavior, autonomic regulation, sleep-related burden, ventricular activation, structural-risk surrogates, or other domains may be more informative when interpreted relative to the patient's own prior state. A trajectory may demonstrate deterioration, improvement, stability, intermittent recurrence, or increasing variability. The study evaluates whether such trajectories contribute to clinician assessment of disease progression, treatment response, recovery, or need for further evaluation.
Study Type
OBSERVATIONAL
Enrollment
1,000
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.
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.
Peerbridge Health, Inc.
Pasadena, California, United States
Peerbridge Health, Inc.
Nashville, Tennessee, United States
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.
Time frame: At clinician review of each Cor360 report; outcomes aggregated through study completion, up to 48 months.
Impact of Cor360 on Clinician Assessment and Intended Care Pathway
Proportion of evaluable paired cases in which review of the Cor360 report results in a documented change, refinement, or confirmation of the clinician's assessment or intended care pathway compared with the clinician's locked pre-report assessment. Domains assessed may include overall cardiac risk or urgency of follow-up; prioritized cardiac phenotype; rhythm or arrhythmia assessment; heart-failure or ejection-fraction-related concern; ischemia, conduction, repolarization, or structural-marker concern; sleep-disordered-breathing or cardiopulmonary concern; additional testing, referral, repeat monitoring, or longitudinal follow-up; and clinician confidence. Results include the proportion changed/refined, the proportion confirmed without change, and, where independent reference information exists, the direction of change relative to that reference, including net appropriate reclassification.
Time frame: 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
Concordance of Cor360-generated phenotypes, risk categories, or indication-level findings with available independent clinical reference information, standard-of-care diagnostic results, or blinded expert review. Reference information may include 12-lead ECG, standard Holter or ambulatory ECG, echocardiography, MRI or CT imaging, laboratory results, sleep testing, clinical diagnosis, adjudicated chart review, or expert-panel review. Agreement is evaluated at the domain or indication level using metrics appropriate to the output and reference, including overall percent agreement, positive percent agreement (PPA), negative percent agreement (NPA), sensitivity, specificity, area under the receiver-operating-characteristic curve, correlation, classification agreement, or weighted kappa. Absence of suitable reference information is treated as not evaluable rather than discordant.
Time frame: 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.
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