Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-11 @ 2:44 PM
Study NCT ID:
NCT03664102
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2018-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Fastener Device Versus Manually Tied Knot in MiAVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac surgery times', 'timeFrame': 'peroperative data', 'description': 'Aortic cross-clamping and cardiopulmonary bypass times'}], 'secondaryOutcomes': [{'measure': 'Morbimortality', 'timeFrame': 'Perioperative (30 days) and 24 months follow up', 'description': 'Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Valve Diseases']}, 'descriptionModule': {'briefSummary': "The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT).\n\nFour hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158.\n\nThe aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient operated on an Isolated aortic valve replacement with stented prosthesis by Minimally-invasive approach (right anterior minithoracotomy)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* Elective patient\n* Isolated aortic valve replacement with stented prosthesis\n* Minimally-invasive approach (right anterior minithoracotomy)\n\nExclusion Criteria:\n\n* Associated procedure\n* Aortic valve replacement with sutureless or rapid valve deployment prosthesis\n* Active endocarditis\n* Prior cardiac surgery'}, 'identificationModule': {'nctId': 'NCT03664102', 'briefTitle': 'Automated Fastener Device Versus Manually Tied Knot in MiAVR', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier La Chartreuse'}, 'officialTitle': 'Comparison of Automated Fastener Device Versus Manually Tied Knot in Minimally-invasive Isolated Aortic Valve Replacement Surgery', 'orgStudyIdInfo': {'id': 'CCVT-MORGANT 082018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sutures with hand-tied knots', 'description': 'Minimally-invasive isolated aortic valve replacement with Sutures were secured with hand-tied knots'}, {'label': 'Sutures with automated fastener device (Cor-Knot)', 'description': 'Minimally-invasive isolated aortic valve replacement with Sutures were secured with automated fastener device (Cor-Knot)', 'interventionNames': ['Device: Cor Knot']}], 'interventions': [{'name': 'Cor Knot', 'type': 'DEVICE', 'description': 'Heart valve replacement with or without the use of automated fastener device Cor Knot', 'armGroupLabels': ['Sutures with automated fastener device (Cor-Knot)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Trial on medical records only. No specific regulatory authorization required. The trial has already been recorded as Professionnal evaluation practices.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier La Chartreuse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'MORGANT Marie-Catherine', 'investigatorAffiliation': 'Centre Hospitalier La Chartreuse'}}}}