Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-28 @ 6:55 PM
Study NCT ID:
NCT06870734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-11
First Post:
2025-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-03-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pacemaker implantation', 'timeFrame': '7 to 30 days', 'description': 'Pacemaker implantation during the index hospitalisation'}], 'primaryOutcomes': [{'measure': 'Primary endpoint', 'timeFrame': '7 days', 'description': 'Composite endpoint combining mortality and stroke in the first post-operative week'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '7 days', 'description': 'Death occuring during the first week after intervention'}, {'measure': 'Stroke', 'timeFrame': '7 days', 'description': 'Stroke occuring during the first week after the intervention'}, {'measure': '30 day mortality', 'timeFrame': '30 days', 'description': 'Death occuring during the first month after intervention'}, {'measure': '1 year mortality', 'timeFrame': '1 year', 'description': 'Death occuring during the first year after intervention'}, {'measure': 'Vasopressive drugs', 'timeFrame': '1 day', 'description': 'Use of vasopressive drugs during the intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['general anesthesia', 'cervical block', 'locoregional anesthesia', 'TAVR', 'cardiovascvular intervention'], 'conditions': ['Aortic Stenosis']}, 'descriptionModule': {'briefSummary': 'Transcarotid transcatheter aortic valve replacement (Transcarotid TAVR) has been increasingly used as an alternative to the transfemoral approach. The general anesthesia, locoragional anesthesia or local anesthesia are three anesthesia techniques that can be used for transcarotid TAVR. We aim to compare the locoregional approach to gerneral anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients who underwent a transcarotid TAVR at the University Hospital of Caen between October 2021 (when the first TAVR was performed under locoregional anesthesia) and December 2024', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients who underwent a transcarotid TAVR at the University Hospital of Caen between October 2021 (when the first TAVR was performed under locoregional anesthesia) and December 2024\n\nExclusion Criteria:\n\n* Patient's refusal to allow data collection and lack of data regarding the primary endpoint"}, 'identificationModule': {'nctId': 'NCT06870734', 'acronym': 'GALATTAVI', 'briefTitle': 'General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement - a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '2024102821344400000170001538'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General anesthesia', 'description': 'Patients undergoing transcarotid transaortic valve replacement under general anesthesia'}, {'label': 'Regional anesthesia', 'description': 'Patients undergoing transcarotid transaortic valve replacement under regional anesthesia'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Richard DESCAMPS, MD', 'role': 'CONTACT', 'email': 'descamps-r@chu-caen.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Richard DESCAMPS', 'investigatorAffiliation': 'University Hospital, Caen'}}}}