Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-31 @ 2:01 PM
Study NCT ID:
NCT04292405
Status:
TERMINATED
Last Update Posted:
2025-10-30
First Post:
2020-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Unable to enroll suitable subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2020-02-28', 'studyFirstSubmitQcDate': '2020-02-28', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CABs comparison', 'timeFrame': '2 hours', 'description': 'Simultaneous CABs recordings from the AUDICOR and WCD devices will be compared'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) as compared to the AUDICOR AM acoustic cardiography recorder.', 'detailedDescription': 'Single arm, prospective, non significant risk device study to evaluate data accuracy of cardiac acoustic biomarkers (CABs) recorded by the Wearable Cardioverter Defibrillator (WCD) compared with the CABs data simultaneously recorded by an acoustic cardiography recorder, the AUDICOR AM device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care, Heart Failure, and Cardiology', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* heart failure or a history of heart failure\n* ischemic or non-ischemic cardiomyopathy\n* ejection Fraction less than or equal to 40% as measured within the last 6 months\n\nExclusion Criteria:\n\n* implanted left ventricular assist device\n* pacemaker dependency\n* currently hospitalized\n* atrial fibrillation on their last ECG or having an irregularly irregular pulse'}, 'identificationModule': {'nctId': 'NCT04292405', 'acronym': 'ACAB', 'briefTitle': 'Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zoll Medical Corporation'}, 'officialTitle': 'Accuracy of Cardiac Acoustic Biomarkers Recorded by the Wearable Cardioverter Defibrillator', 'orgStudyIdInfo': {'id': '90d0214'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Heart Failure Patients', 'description': 'Simultaneous recordings of cardiac acoustic biomarkers (CABs) by the Wearable Cardioverter Defibrillator and the AUDICOR AM', 'interventionNames': ['Device: Wearable Cardioverter Defibrillator']}], 'interventions': [{'name': 'Wearable Cardioverter Defibrillator', 'type': 'DEVICE', 'otherNames': ['AUDICOR AM'], 'description': 'Use of the Wearable Cardioverter Defibrillator and AUDICOR AM to evaluate accuracy of cardiac acoustic biomarker recordings.', 'armGroupLabels': ['Heart Failure Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'MAYO Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Mike Osz', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director, Clinical Operations, ZOLL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}