Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
Study NCT ID:
NCT04802200
Status:
COMPLETED
Last Update Posted:
2022-04-18
First Post:
2021-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-15', 'studyFirstSubmitDate': '2021-03-11', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of major access site vascular complications', 'timeFrame': '30 days', 'description': 'according to the Valve Academic Research Consortium (VARC)-2 and Bleeding Academic Research Consortium (BARC)-2 definition criteria in postoperative period'}, {'measure': 'Hemostasis success', 'timeFrame': '10 min', 'description': 'Hemostasis at the puncture site of cutting the MANTA suture without need for manual or mechanical compression and without late re-bleeding'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Femoral Artery Injury', 'Aortic Valve Insufficiency']}, 'descriptionModule': {'briefSummary': 'The percutaneous MANTA Vascular Closure Device is dedicated to the closure of large bore arteriotomies. It appears to be a safe and doable option for vascular access closure in patients undergoing transfemoral Transcatheter Aortic Valve Implantation. Data concerning safety and efficacy of MANTA Vascular Closure Device in Minimally Invasive Cardiac Surgery are scarce. This study aim to assess this novel collagen-based technology in minimal invasive aortic valve replacement surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subject adult voluntarily agreeing to participate in the study operated between December 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University Hospital, in whom the MANTA device has been used for femoral artery closure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject voluntarily agreeing to participate in the study\n* Subject \\>= 18 years of age\n* Patients operated between december 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University Hospital\n* Patients in whom the MANTA device has been used for femoral artery closure\n\nExclusion Criteria:\n\nNot applicable'}, 'identificationModule': {'nctId': 'NCT04802200', 'acronym': 'MANTA-MICS', 'briefTitle': 'Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Short-term Clinical Follow-up of the Vascular Closure Device MANTATM in Minimally Invasive Cardiac Surgery', 'orgStudyIdInfo': {'id': 'HAMDAN 2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients operated from minimally invasive cardiac surgery', 'description': 'Patients operated between December 16, 2019 and june 30, 2021 from minimally invasive cardiac surgery with femoral cannulation for cardiopulmonary bypass in Dijon University hospital and in whom the MANTA device has been used for femoral artery closure', 'interventionNames': ['Other: Data collect']}], 'interventions': [{'name': 'Data collect', 'type': 'OTHER', 'description': 'Data collect following a vascular closure by MANTA', 'armGroupLabels': ['Patients operated from minimally invasive cardiac surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}