Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-30 @ 12:50 AM
Study NCT ID:
NCT04024566
Status:
WITHDRAWN
Last Update Posted:
2022-07-20
First Post:
2019-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Non-invasive Detection of Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006337', 'term': 'Heart Murmurs'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Company changed strategic direction in Oct 2019 (staff changes; no one at company who participated in this study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2019-07-16', 'studyFirstSubmitQcDate': '2019-07-16', 'lastUpdatePostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optimized algorithm for diagnosis of AS', 'timeFrame': '2 years', 'description': 'Data collected in this study will be analyzed by multiple mathematical approaches to develop an optimized algorithm for detection of severe AS'}], 'secondaryOutcomes': [{'measure': 'Positive predictive value (PPV) of Vivio in the diagnosis of severe AS', 'timeFrame': '2 years', 'description': 'PPV for detecting AS by Vivio compared to PPV for 2D TTE'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['echocardiography'], 'conditions': ['Heart Valve Diseases', 'Aortic Valve Disease', 'Heart Murmurs']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ahmed AK, Garberich R, Gossl M, Tindell L, Williams K, Dennis S, Bae R, Soraja P. A novel method of non-invasive screening for patients with aortic stenosis. JACC March 12, 2019, 73 (9 Supplement 1) 1995; DOI:10.1016/S0735-1097(19)32601-4'}]}, 'descriptionModule': {'briefSummary': "Avicena is developing new non-invasive methods (hardware and software) for diagnosis of a variety of heart conditions. This study is designed to compare data obtained using Avicena's device, the Vivio, to data obtained from transthoracic echocardiography (TTE) for the diagnosis of moderate-to-severe aortic stenosis. Aortic stenosis (AS) is a disease of the valve (aortic valve) that separates the left ventricle of the heart from the aorta. When AS is severe, the heart cannot pump adequate amounts of blood into the arterial tree. AS is often silent until the disease is severe. This study compares a rapid test using Vivio to a longer and more expensive test that is the current gold standard for diagnosis of AS, TTE.", 'detailedDescription': "The study proposed here is a research study to develop the Vivio system for diagnosis of severe AS. The data gathered in this study will be used to optimize the Avicena software algorithm used to make the diagnosis of AS.\n\nThe Vivio device is an optical-type tonometer that operates based on capturing the vibrations of the skin due to the arterial pulse pressure wave as it propagates through the underlying carotid vessel. When applied to the neck over the subject's carotid pulse, an arterial waveform (pressure tracing) and heart sounds are sensed, and sent to an iPad using Bluetooth, then sent to Avicena for analysis.\n\nAfter informed consent subjects will undergo a brief cardiac-focused history and examination. All subjects will have bilateral exams with the Vivio (\\~5 minutes each) conducted by a study doctor or nurse, and a standard clinical resting TTE conducted by a certified technician. The entire study visit should take 1.5 hours, and there is no follow up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Severe, symptomatic AS incidence increases with age, so that most patients do not experience symptoms until after age 60. For this reason, to enrich for the population of patients with potential AS, subjects over age 65 will be studied.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult subjects \\>60 years of age\n2. Ability to understand and sign informed consent\n3. Willingness to undergo study protocol (in Pasadena CA)\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck)\n3. History of significant or symptomatic carotid artery disease, or carotid artery stenting or surgery\n4. History of aortic valve surgery or transcatheter aortic valve replacement\n5. Absent carotid pulse on initial examination (inability to palpate the carotid pulse)\n6. Open skin lesions at the site of Vivio application/examination\n7. Presence of a carotid bruit on examination'}, 'identificationModule': {'nctId': 'NCT04024566', 'briefTitle': 'Rapid Non-invasive Detection of Aortic Stenosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avicena LLC'}, 'officialTitle': 'Aortic Stenosis Screening Using the Avicena Vivio System', 'orgStudyIdInfo': {'id': 'AS20192'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vivio System', 'type': 'DEVICE', 'description': 'Optical/sensor tonometer applied to the neck over the carotid pulse (bilateral)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Avicena', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Sean Brady, JD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chief Executive Officer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avicena LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}