Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-01 @ 8:03 PM
Study NCT ID:
NCT03027804
Status:
WITHDRAWN
Last Update Posted:
2023-06-07
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ross Operation Failure Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'This study has been changed in systematic review and meta-analysis', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2017-01-18', 'studyFirstSubmitQcDate': '2017-01-19', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'from inclusion to 20 years follow-up', 'description': 'Death from any cause'}, {'measure': 'Cardiac Death', 'timeFrame': 'from inclusion to 20 years follow-up', 'description': 'Mortality due to cardiac cause'}, {'measure': 'Reoperation for Pulmonary Autograft Failure', 'timeFrame': 'from inclusion to 20 years follow-up', 'description': 'Need for reoperation due to failure of pulmonary autograft or valve degeneration'}, {'measure': 'Stroke', 'timeFrame': 'from inclusion to 20 years follow-up', 'description': 'neurological stroke with impairment'}, {'measure': 'Rehospitalization for heart failure', 'timeFrame': 'from inclusion to 20 years follow-up', 'description': 'Readmission to hospital for heart failure'}, {'measure': 'Quality of life-1', 'timeFrame': 'from inclusion to 20 years follow-up', 'description': 'Quality of life as measured with SF-12'}, {'measure': 'Quality of life-2', 'timeFrame': 'from inclusion to 20 years follow-up', 'description': 'Quality of life as measured with Minnesota living with heart failure questionnaire'}, {'measure': 'Quality of life-3', 'timeFrame': 'from inclusion to 20 years follow-up', 'description': 'Quality of life as measured withEQ 5D score'}], 'secondaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': 'postoperative period (1-30 days)', 'description': 'Combined outcome including bleeding, arrhythmia, respiratory failure, renal failure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ross Operation', 'Pulmonary Autograft', 'Structural Valve Degeneration']}, 'descriptionModule': {'briefSummary': "A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure phenomenon and feed more complex biomechanical models to be integrated with clinical imaging with the final aim to predict Ross operation's outcomes and define strategies to ameliorate its results.", 'detailedDescription': 'On the basis of the current knowledge on the outcomes of Ross Operation we aim to create a large multi centric registry in order to obtain data on the preoperative intraoperative management of these patients and on the postoperative long-term results of this procedure.\n\nPatients data will be entered by the investigators in an electronic database Preoperative variables will include age, comorbidities, functional status, indications for surgery, morphology of the aortic valve Additional morphological data and aortic and pulmonary measurements will be taken intraoperatively Postoperative follow-up data including both clinical outcomes (mortality, reoperation for pulmonary autograft failure, major cardiac events, stroke, infection) and morphological measurements by means of CT scan or echocardiography, will be inserted.\n\nQuality of life by means of SF12 and Minnesota living with heart failure questionnaire and EQ-5D score will be collected.\n\nFollow-up endpoints are at discharge, 1 year 5 years 10 years 15 years and 20 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergone (or undergoing) to Ross Operation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergone (or undergoing) to Ross Operation\n\nExclusion Criteria:\n\n* Patients requiring combined cardiac surgical procedure in association to Ross Operation'}, 'identificationModule': {'nctId': 'NCT03027804', 'acronym': 'ROFDA', 'briefTitle': 'Ross Operation Failure Database', 'organization': {'class': 'OTHER', 'fullName': 'Centre Cardiologique du Nord'}, 'officialTitle': 'Database on Ross Operation Failures and Outcomes', 'orgStudyIdInfo': {'id': 'CN-17-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ross Operation', 'description': 'Patients undergone Ross Operation. Patients requiring reoperation', 'interventionNames': ['Procedure: Ross Operation']}], 'interventions': [{'name': 'Ross Operation', 'type': 'PROCEDURE', 'description': 'Replacement of the aortic valve by means of pulmonary artery autograft', 'armGroupLabels': ['Ross Operation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Centre Cardiologique Du Nord', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Francesco Nappi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Cardiologique du Nord'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Cardiologique du Nord', 'class': 'OTHER'}, 'collaborators': [{'name': 'Golden Jubilee National Hospital', 'class': 'OTHER_GOV'}, {'name': 'University of Bern', 'class': 'OTHER'}, {'name': 'Pontifícia Universidade Católica do Paraná', 'class': 'OTHER'}, {'name': 'Ospedale San Donato', 'class': 'OTHER'}, {'name': 'Groupe Hospitalier Pitie-Salpetriere', 'class': 'OTHER'}, {'name': "Royal Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}