Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-28 @ 3:04 AM
Study NCT ID:
NCT02278666
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2014-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D065467', 'term': 'Transcatheter Aortic Valve Replacement'}], 'ancestors': [{'id': 'D019918', 'term': 'Heart Valve Prosthesis Implantation'}, {'id': 'D006348', 'term': 'Cardiac Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-11', 'studyFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2014-10-28', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiopulmonary bypass time', 'timeFrame': 'during surgery'}, {'measure': 'Total duration of Intensive Care Unit stay', 'timeFrame': 'during hospital stay, usually lasting one to two weeks'}, {'measure': 'Blood transfusions', 'timeFrame': 'during hospital stay, usually lasting one to two weeks'}], 'secondaryOutcomes': [{'measure': 'renal insufficiency', 'timeFrame': 'during hospital stay, usually lasting one to two weeks', 'description': 'need for haemofiltration'}, {'measure': 'Prolonged ventilation', 'timeFrame': 'during hospital stay', 'description': 'longer than 24 hours'}, {'measure': 'Re-exploration for bleeding', 'timeFrame': 'during hospital stay, usually lasting one to two weeks', 'description': 'need of surgical revision for bleeding'}, {'measure': 'sepsis', 'timeFrame': 'during hospital stay, usually lasting one to two weeks'}, {'measure': 'Neurological complications', 'timeFrame': 'during hospital stay, usually lasting one to two weeks', 'description': 'stroke and/or transient ischemic attacks'}, {'measure': 'in-hospital mortality', 'timeFrame': 'during hospital stay, usually lasting one to two weeks'}, {'measure': '30-day mortality', 'timeFrame': '30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Aortic Valve Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.', 'detailedDescription': 'The study will focus on data recorded and collected from daily clinical treatment of patients undergoing isolated aortic valve replacement due to symptomatic aortic stenosis who consented to the use of their personal data. After surgery patients will be followed up to a minimum of 12 months. In-hospital and follow-up outcomes of the different surgical approaches will be analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing isolated aortic valve surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing isolated aortic valve surgery\n* Written Informed consent to the use of personal data\n\nExclusion Criteria:\n\n* other associated cardiac surgery\n* emergency surgery'}, 'identificationModule': {'nctId': 'NCT02278666', 'acronym': 'SATURNO', 'briefTitle': 'Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry', 'organization': {'class': 'OTHER', 'fullName': 'Maria Cecilia Hospital'}, 'officialTitle': 'Minimally Invasive Aortic Valve Replacement Versus Conventional Aortic Valve Replacement: a Long Term Registry on Potential Benefits of the Different Surgical Techniques', 'orgStudyIdInfo': {'id': 'ESREFO21'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'upper mini-sternotomy', 'description': 'aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)', 'interventionNames': ['Procedure: aortic valve replacement', 'Device: biological prosthetic valve', 'Device: Mechanical valve']}, {'label': 'right mini thoracotomy', 'description': 'aortic valve replacement/repair surgery via right mini thoracotomy', 'interventionNames': ['Procedure: aortic valve replacement', 'Device: biological prosthetic valve', 'Device: Mechanical valve']}, {'label': 'conventional sternotomy', 'description': 'aortic valve replacement surgery via conventional full sternotomy', 'interventionNames': ['Procedure: aortic valve replacement', 'Device: biological prosthetic valve', 'Device: Mechanical valve']}], 'interventions': [{'name': 'aortic valve replacement', 'type': 'PROCEDURE', 'otherNames': ['AVR'], 'description': 'aortic valve replacement with either biological prosthetic valve or mechanical valve', 'armGroupLabels': ['conventional sternotomy', 'right mini thoracotomy', 'upper mini-sternotomy']}, {'name': 'biological prosthetic valve', 'type': 'DEVICE', 'description': 'aortic valve replacement with either biological prosthetic valve or mechanical valve', 'armGroupLabels': ['conventional sternotomy', 'right mini thoracotomy', 'upper mini-sternotomy']}, {'name': 'Mechanical valve', 'type': 'DEVICE', 'description': 'aortic valve replacement with either biological prosthetic valve or mechanical valve', 'armGroupLabels': ['conventional sternotomy', 'right mini thoracotomy', 'upper mini-sternotomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48010', 'city': 'Cotignola', 'state': 'Ravenna', 'country': 'Italy', 'facility': 'Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}], 'overallOfficials': [{'name': 'Elisa Mikus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maria Cecilia Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Cecilia Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ettore Sansavini Health Science Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}