Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04068402
Status:
WITHDRAWN
Last Update Posted:
2022-07-20
First Post:
2019-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vivio AS (Aortic Stenosis) Algorithm Optimization Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking required'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Company changed strategic direction in Oct 2019', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint - Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis.', 'timeFrame': '48 hours', 'description': 'Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis.'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study', 'timeFrame': '48 hours', 'description': 'Incidence of Adverse Events: Summary of all reported adverse events during the study. Events will be summarized by seriousness (e.g. serious vs. non-serious), attribution (e.g. device vs. procedure vs. comorbidity) based upon site reported data.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis', 'detailedDescription': 'Prospective, non-randomized, single-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 1 site\n\nEnrolled subjects will undergo:\n\nVivio system data capture, standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult subjects (21 years of age or older).\n2. Referred for transthoracic echocardiography by physician/primary care provider/cardiologist.\n3. Willing and able to participate in all study evaluations and allow access to medical testing and records.\n4. Ability to understand and sign an informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.\n\nExclusion Criteria:\n\n1. Acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical circulatory support.\n2. Need for bedside echocardiogram (inpatient).\n3. Prosthetic device previously implanted at aortic valve position.\n4. Inability to palpate carotid pulse\n5. History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).\n6. History of significant carotid artery disease or treatment (surgery, stenting, \\> 50% stenosis in both left and right carotid artery).\n7. Open skin lesions at target site of Vivio examination.'}, 'identificationModule': {'nctId': 'NCT04068402', 'briefTitle': 'Vivio AS (Aortic Stenosis) Algorithm Optimization Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avicena LLC'}, 'officialTitle': 'Optimization of the Vivio System Algorithm as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis', 'orgStudyIdInfo': {'id': 'VS-001-AO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Device: Vivio System']}], 'interventions': [{'name': 'Vivio System', 'type': 'DEVICE', 'description': 'The Vivio System is an electronic auscultatory device and optical sensor, plus software application intended to provide support to the physician in the evaluation of heart sounds in patients. The product will analyze the acoustic signals of the heart and signals from a captured arterial (carotid) waveform. The analysis procedure will identify and analyze specific heart sounds and arterial waveform features captured by the Vivio device, to devise a scoring system for severe aortic stenosis.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'overallOfficials': [{'name': 'Sean Brady, JD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avicena LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avicena LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}