Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT07202104
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome', 'timeFrame': '6 months', 'description': 'Evaluate a machine learning model\'s ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and review by an expert panel of cardiologists.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['structural heart disease', 'structural murmur'], 'conditions': ['Structural Heart Disease']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate a machine learning model\'s ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and reviewed by an expert panel of cardiologists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potential research subjects will be screened for eligibility from cardiology clinics, echocardiogram clinics, and inpatient areas. In order to be eligible, a patient must be 18+ years of age, have a documented history of structural heart disease, and has undergone an echocardiogram within the last 30 days. If a patient meets all of the specified inclusion criteria, and none of the specified exclusion criteria, the patient or their proxy will be approached to discuss participation in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18+ years old\n* Patient or patient's legal healthcare proxy consents to participation\n* Documented history of SHD\n* Undergoing (or has undergone, within 30 days) a complete echocardiogram\n* Willing to have heart recordings done with two different electronic stethoscopes\n\nExclusion Criteria:\n\n* Patient or proxy is unwilling/unable to give written informed consent\n* Unable to complete a complete echocardiogram, or none recent completed within the last 30 days\n* No documented history of SHD\n* Experiencing a known or suspected acute cardiac event\n* Mechanical ventricular support (such as ECMO, LVAD, RVAD, BiVAD, Impella, intra-aortic balloon pumps, TAH, VentrAssist, DuraHeart, HVAD, EVAHEART LVAS, HeartMate, Jarvik 2000)\n* Unwilling or unable to follow or complete study procedures"}, 'identificationModule': {'nctId': 'NCT07202104', 'briefTitle': 'Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eko Devices, Inc.'}, 'officialTitle': 'Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes', 'orgStudyIdInfo': {'id': '2025.1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Eko digital stethoscopes', 'type': 'DEVICE', 'description': 'Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to auscultate and record cardiac phonocardiogram and (when available) electrocardiogram waveforms, as well as heart sounds.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'Christopher.Schulze@coxhealth.com', 'phone': '(417) 875-2626'}], 'facility': 'Cox Medical Centers', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}], 'centralContacts': [{'name': 'Clinical Research Associate', 'role': 'CONTACT', 'email': 'jackrin.walsh@ekohealth.com', 'phone': '8443563384'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eko Devices, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}