[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603446":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":30,"overallOfficials":42,"centralContacts":47,"locations":53,"responsibleParty":89,"collaborators":17,"id":91,"slug":17,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":17,"enrollmentInfo":101,"targetDuration":17,"studyType":104,"phases":17,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":56,"whyStopped":17,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Eko Devices, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Area under the receiver operating characteristic (ROC) curve (AUC) for pulmonary hypertension (PH) detection","Description: Area under the receiver operating characteristic (ROC) curve (AUC) of the phonocardiogram (PCG) + electrocardiogram (ECG) algorithm for classifying pulmonary hypertension (PH) vs. non-PH using probability outputs; reference is transthoracic echocardiography (TTE) and\u002For right heart catheterization (RHC) within ±7 days. 95% confidence intervals (CIs) reported.","Study completion (up to 12 months); reference within ±7 days.",[14],{"measure":15,"description":16,"timeFrame":12},"Positive and negative predictive values for PH detection","Positive predictive value (PPV) and negative predictive value (NPV) at a prespecified operating point; reference is transthoracic echocardiography (TTE) and\u002For right heart catheterization (RHC) within ±7 days. 95% confidence intervals (CIs) reported.",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","This is a prospective, observational, multi-site study to determine whether synchronized heart-sound (phonocardiogram; PCG) and three-lead electrocardiogram (ECG) recordings (entered as separate interventions in PRS, though collected together in practice) collected with the FDA (U.S. Food and Drug Administration)-cleared Eko CORE 500 digital stethoscope can assist in screening for pulmonary hypertension (PH). Adults (≥18 years) referred for clinically indicated transthoracic echocardiography (TTE) and\u002For right heart catheterization (RHC) will complete a single study visit (\\~20 minutes). During the visit, trained staff will obtain at least four 15-second CORE 500 recordings from standard auscultation locations (aortic, pulmonic, tricuspid, and mitral).\n\nThe clinical TTE (and RHC, if performed) completed within ±7 days of the recordings will provide reference labels for the presence and severity of PH. If available, de-identified results from a clinical 12-lead ECG performed within 30 days of the TTE may also be abstracted for comparison. The primary objective is to develop and validate a software algorithm that detects PH from PCG+ECG signals; secondary objectives include assessing severity stratification and overall diagnostic performance (e.g., sensitivity\u002Fspecificity, area under the receiver operating characteristic curve \\[AUC\\], positive predictive value \\[PPV\\], negative predictive value \\[NPV\\]), including subgroup analyses to evaluate generalizability. These recordings are investigational data acquisitions for algorithm development and detection research only; they are not diagnostic procedures and will not be used for clinical decision-making.\n\nThe study plans to enroll up to \\~1,513 participants to obtain approximately 1,375 evaluable datasets (about 1,250 with TTE and 125 with RHC). No clinical decisions will be based on investigational algorithm outputs, and participation does not alter standard care. Key eligibility includes adults able to consent who have a clinical TTE or RHC within the protocol window; exclusions include current hospitalization and limited TTE studies. All study data are de-identified using site-maintained key-coded identification codes (IDs). PCG\u002FECG recordings are transmitted to a HIPAA (Health Insurance Portability and Accountability Act)-compliant, secure server; de-identified demographics, clinical data (e.g., TTE Doppler measures including TR \\[tricuspid regurgitation\\] velocity and estimated pulmonary artery systolic pressure, RHC hemodynamics), and relevant reports\u002Fimages may be abstracted\u002Fuploaded per site procedures.\n\nThis minimal-risk study has IRB (Institutional Review Board) approval. No independent data monitoring committee is appointed; safety oversight is provided by site investigators with adverse event reporting per IRB policy. There is no cost to participants; modest compensation (≤$50, site-specific) may be provided. The CORE 500 hardware is FDA-cleared; however, the software algorithm evaluated in this study is investigational (not FDA-cleared). The aim is regulatory readiness for potential future submission without committing to a specific regulatory filing as part of this study.","Adults (≥18 years) receiving outpatient cardiovascular care at participating U.S. centers who are scheduled for, or have recently undergone, clinically indicated transthoracic echocardiography (TTE) and\u002For right heart catheterization (RHC) within ±7 days of the study visit. Participants are recruited consecutively from clinic and echo\u002FRHC schedules; hospitalized patients are excluded. The population will include individuals with and without pulmonary hypertension across diverse demographics.",[24],{"label":25,"type":17,"description":26,"interventionNames":27},"Outpatient Echo\u002FRHC Patients","Outpatient Echo\u002FRHC Patients\n\nAdults (≥18) referred for clinically indicated transthoracic echocardiography (TTE) and\u002For right heart catheterization (RHC). One study visit (\\~20 minutes) to obtain ≥4 15-second Eko CORE 500 recordings (phonocardiogram and three-lead electrocardiogram) at standard auscultation sites. No randomization or changes to standard care; investigational algorithm outputs are not used clinically. TTE and\u002For RHC performed within ±7 days provide reference labels for presence\u002Fseverity of pulmonary hypertension.",[28,29],"Diagnostic Test: Eko CORE 500 phonocardiogram (PCG) recording","Diagnostic Test: Eko CORE 500 three-lead electrocardiogram (ECG) recording",[31,38],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DIAGNOSTIC_TEST","Eko CORE 500 phonocardiogram (PCG) recording","Noninvasive acquisition of heart sound (phonocardiogram, PCG) recordings using the FDA (U.S. Food and Drug Administration)-cleared Eko CORE 500 digital stethoscope. At least four 15-second recordings are collected at standard auscultation sites (aortic, pulmonic, tricuspid, mitral). Recordings are used solely for investigational algorithm development and are not used for diagnostic or clinical decision-making.",[25],[37],"Eko CORE 500",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":17},"Eko CORE 500 three-lead electrocardiogram (ECG) recording","Noninvasive acquisition of three-lead electrocardiogram (ECG) signals using the FDA-cleared Eko CORE 500 digital stethoscope. Recordings are obtained simultaneously with PCG at auscultation sites. Data are used solely for investigational algorithm development and are not intended for diagnostic use.",[25],[43],{"name":44,"affiliation":45,"role":46},"Michael Troy, MD","University of California, Los Angeles","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":17,"email":52},"Nicole Sutter, MPH","CONTACT","707-280-7059","colie.sutter@ekohealth.com",[54,73],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University of California Los Angeles","RECRUITING","Los Angeles","California","90095","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-118.24368,34.05223,{"lat":66,"lon":65},[69],{"name":70,"role":50,"phone":71,"phoneExt":17,"email":72},"Lloyd Liang","1 (800) 900-UCLA","LLLiang@mednet.ucla.edu",{"facility":74,"status":56,"city":75,"state":76,"zip":77,"country":60,"countryCode":61,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Duke University","Durham","North Carolina","27708",{"type":63,"coordinates":79},[80,81],-78.89862,35.99403,{"lat":81,"lon":80},[84,88],{"name":85,"role":50,"phone":86,"phoneExt":17,"email":87},"Marat Fudim, MD, MHS","(919) 681-5816","marat.fudim@duke.edu",{"name":85,"role":46,"phone":17,"phoneExt":17,"email":17},{"type":90,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100603446",false,"NCT07136623","Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope","Deep Learning for Algorithmic Detection of Pulmonary Hypertension Using a Combined Digital Stethoscope and Three-lead Electrocardiogram","EKO-PH","Inclusion Criteria:\n\nAge ≥ 18 years.\n\nAble and willing to provide informed consent.\n\nClinically indicated transthoracic echocardiogram (TTE) or right heart catheterization (RHC) scheduled\u002Fperformed within ±7 days of the study recording visit.\n\nExclusion Criteria:\n\nUnwilling or unable to provide informed consent.\n\nCurrently hospitalized at the time of study procedures.\n\nIf enrolled via TTE path: limited (non-diagnostic) echocardiogram.",true,"ALL","18 Years",{"count":102,"type":103},1513,"ESTIMATED","OBSERVATIONAL","This prospective, observational study will evaluate whether synchronized heart sound (phonocardiogram, PCG) and three-lead electrocardiogram (ECG) recordings (entered as separate interventions in PRS, though collected together in practice) collected with the Eko CORE 500 can help screen for pulmonary hypertension (PH). Adults (≥18 years) undergoing clinically indicated transthoracic echocardiography (TTE) and\u002For right heart catheterization (RHC) will complete one study visit (\\~20 minutes). During the visit, study staff will obtain at least four 15-second CORE 500 recordings (aortic, pulmonic, tricuspid, and mitral areas). The clinical echocardiogram (and RHC, if performed) within ±7 days of the recordings will provide reference labels for the presence and severity of PH; de-identified demographic and clinical data may also be abstracted from the medical record.\n\nThe primary objective is to develop and validate a software algorithm to detect PH and, where possible, stratify severity using noninvasive PCG+ECG signals. These recordings are investigational data acquisitions for algorithm development only; they are not diagnostic procedures and will not be used for clinical decision-making. Primary performance measures are sensitivity and specificity versus echocardiogram and RHC references. No clinical decisions will be based on the investigational algorithm, and no changes to standard care are required. The study plans to enroll up to \\~1,513 participants to obtain approximately 1,375 evaluable datasets across multiple outpatient sites.",[107],"Pulmnary Hypertension",[109],"pulmonary hypertension","2026-06-15",{"date":112,"type":113},"2026-06-17","ACTUAL",{"date":115,"type":113},"2025-08-01",{"date":117,"type":103},"2027-05-31",{"name":5,"class":6},2]