Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-25 @ 11:46 PM
Study NCT ID:
NCT03681834
Status:
UNKNOWN
Last Update Posted:
2018-09-24
First Post:
2018-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 364}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2018-08-28', 'studyFirstSubmitQcDate': '2018-09-20', 'lastUpdatePostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of periprosthetic leak around the prosthetic rings as determined during physical examination (rated yes/no )', 'timeFrame': 'Day 30'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vascular Surgery']}, 'descriptionModule': {'briefSummary': 'The Cor-Knot® device is an automated knotting system for valve sutures and prosthetic rings used for more than a year during valve replacements and annuloplasties in cardiac surgery. It reduces the time spent knotting the threads fixing the prosthesis and thus reduces aortic clamping and extracorporeal circulation times. The originality of the project is based on the absence of national multi-rate data collection on the effectiveness and safety of the Cor-Knot® knotting device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring valve surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* programmed minimally invasive surgery for:\n\n * aortic valve replacement\n * mitral valve replacement\n * mitral valve plastic surgery\n* adult patient\n\nExclusion Criteria:\n\n* emergency surgery'}, 'identificationModule': {'nctId': 'NCT03681834', 'acronym': 'RECORVA', 'briefTitle': 'Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery', 'orgStudyIdInfo': {'id': 'MORGANT 2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Data on the effectiveness and safety of the Cor-Knot® knotting device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Marie-Catherine MORGANT', 'role': 'CONTACT', 'email': 'mariecatherine.morgant@chu-dijon.fr', 'phone': '+33 380293352'}], 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}], 'centralContacts': [{'name': 'Marie-Catherine MORGANT', 'role': 'CONTACT', 'email': 'mariecatherine.morgant@chu-dijon.fr', 'phone': '+33 380293352'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}