Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
Study NCT ID:
NCT04392492
Status:
UNKNOWN
Last Update Posted:
2020-12-02
First Post:
2020-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vascular Closure Device in Transcatheter 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '6 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with major vascular complications', 'timeFrame': '6 week follow up', 'description': 'Major vascular access site complications according to the VARC-2 definitions'}], 'secondaryOutcomes': [{'measure': 'Number of patients with minor vascular complications', 'timeFrame': '6 week follow up', 'description': 'Minor vascular access site complications according to the VARC-2 definitions'}, {'measure': 'Number of patients with vascular closure device failure', 'timeFrame': '6 week follow up', 'description': 'Percutaneous vascular closure device failure according to the VARC-2 definitions'}, {'measure': 'Number of patients with life-threatening, disabling or major bleeding', 'timeFrame': '6 week follow up', 'description': 'Life-threatening, disabling or major bleeding complications according to the BARC definitions'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Valve Stenosis']}, 'referencesModule': {'references': [{'pmid': '35427700', 'type': 'DERIVED', 'citation': 'Kastengren M, Settergren M, Ruck A, Feldt K, Saleh N, Linder R, Verouhis D, Meduri CU, Bager J, Dalen M. Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations. Int J Cardiol. 2022 Jul 15;359:7-13. doi: 10.1016/j.ijcard.2022.04.033. Epub 2022 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety and efficacy of a percutaneous plug-based large-bore vascular closure device for femoral artery closure in an unselected consecutive patient cohort undergoing transcatheter aortic valve implantation in a single-center prospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing TAVI at the Karolinska University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing transfemoral TAVI at the Karolinska University Hospital\n\nExclusion Criteria:\n\n* Patients undergoing TAVI with access other than transfemoral\n* Use of closure device other than MANTA'}, 'identificationModule': {'nctId': 'NCT04392492', 'briefTitle': 'Vascular Closure Device in Transcatheter Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Plug-based Percutaneous Vascular Closure Device in Transcatheter Aortic Valve Replacement', 'orgStudyIdInfo': {'id': 'MANTA TAVI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing transfemoral TAVI with MANTA closure', 'description': 'Patients undergoing transfemoral transcatheter aortic valve replacement with femoral access site closure using the novel plug-based vascular closure device (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA).', 'interventionNames': ['Device: MANTA vascular closure device']}], 'interventions': [{'name': 'MANTA vascular closure device', 'type': 'DEVICE', 'description': 'Femoral access site closure using the MANTA closure device', 'armGroupLabels': ['Patients undergoing transfemoral TAVI with MANTA closure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Cardiology, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Magnus Dalén', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}