Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
Study NCT ID:
NCT07270692
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence
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': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm', 'timeFrame': '15-16 months', 'description': 'The primary objective of this study is to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, by using Eko CORE 500 digital stethoscopes to collect the heart sounds and 3-lead ECG recordings of 500 patients who are 18 years or older and have completed an echocardiogram within 7 days of the study procedures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low ejection fraction'], 'conditions': ['Low Ejection Fraction']}, 'descriptionModule': {'briefSummary': 'The main objectives of this study are to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, using heart sounds and a 3-lead ECG as inputs, as well as determine the impact of gender, age, and race on algorithm performance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will employ an all-comers strategy, indicating that virtually any patient who receives a standard-of-care echocardiogram may participate. The echocardiogram must be within 7 days of the CORE 500 measurements to ensure that the measured ejection fraction is contemporaneous with the heart sounds and 3-lead ECG. This will include both healthy patients and patients with low EF.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Able and willing to provide informed consent\n* Complete a clinical echocardiogram within 7 days before or after study procedures\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent\n* Patients who are hospitalized'}, 'identificationModule': {'nctId': 'NCT07270692', 'briefTitle': 'Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eko Devices, Inc.'}, 'officialTitle': 'Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence', 'orgStudyIdInfo': {'id': '2025.5'}}, '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': '400016', 'city': 'Mumbai', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'udaygandhe@gmail.com', 'phone': '8443563384'}], 'facility': 'P. D. Hinduja Hospital and Medical Research Centre', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], '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'}}}}