Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 4:44 AM
Study NCT ID:
NCT06295068
Status:
TERMINATED
Last Update Posted:
2025-03-30
First Post:
2023-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of ARi With OpSens SavvyWire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001022', 'term': 'Aortic Valve Insufficiency'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Early termination.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2024-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of the Aortic Regurgitation Index (ARi) measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography', 'timeFrame': 'From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours'}], 'secondaryOutcomes': [{'measure': 'Correlation of the Time Integration Aortic Regurgitation Index (TIARI) measured using the SavvyWire compare with regurgitation evaluation derived by Echography (TEE/TTE) and Aortography', 'timeFrame': 'From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours'}, {'measure': 'Correlation of the Aortic Regurgitation Index Ratio measured using the Opsens SavvyWire compare with regurgitation evaluation derived by Echography and Aortography', 'timeFrame': 'From the beginning of the procedure (first measurement is taken before the valve intervention) until to the end of the procedure (second measurement is taken after the valve Intervention), up to 2 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Valve Insufficiency']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire, Echography and Aortography in subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention. The main question it aims to answer is how the ARi measured with the Opsens SavvyWire compared with regurgitation evaluation derived by Echography and Aortography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with severe aortic stenosis (AS) undergoing echo guided valve intervention', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing TAVR suitable for intraoperative acquisition of TEE/TTE\n* Age \\> 18 years\n* Able and willing to give informed consent.\n\nExclusion Criteria:\n\n* Hemodynamic instability making use of additional hemodynamic measurement inappropriate or 24-hour survival unlikely\n* Subject is considered part of a vulnerable population.'}, 'identificationModule': {'nctId': 'NCT06295068', 'acronym': 'ARi', 'briefTitle': 'Evaluation of ARi With OpSens SavvyWire', 'organization': {'class': 'INDUSTRY', 'fullName': 'Opsens, Inc.'}, 'officialTitle': 'Evaluation of the Aortic Regurgitation Index (ARi) Measured With the Opsens SavvyWire to Determine the Correlation Between Regurgitation Evaluation Using Echography and Aortography', 'orgStudyIdInfo': {'id': 'PRT-1400-11'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcatheter Aortic Valve Replacement (TAVR)', 'type': 'DEVICE', 'description': 'Replacement of the aortic valve with use of the OpSens SavvyWire'}, {'name': 'Balloon Aortic Valvuloplasty (BAV)', 'type': 'DEVICE', 'description': 'Dilation of the narrowed aortic valve by balloon inflation with use of the OpSens SavvyWire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'AHS Morristown Medical Center', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}], 'overallOfficials': [{'name': 'Philippe Généreux, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AHS Morristown Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Opsens, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}