Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 3:12 PM
Study NCT ID:
NCT05714228
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2023-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2645}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Euroscore II overall predictive power', 'timeFrame': '30 days postop'}, {'measure': 'Euroscore II predictive power for surgery', 'timeFrame': '30 days postop'}, {'measure': 'Euroscore II predictive power for transcatheter', 'timeFrame': '30 days postop'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mitral Valve Regurgitation']}, 'descriptionModule': {'briefSummary': "The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgery\n\n* However, it has not been validated in patients undergoing surgical or trans- catheter mitral valve repair.\n* The aim of this study is to evaluate the predictive value of the EuroSCORE II in estimating 30-day mortality in a large cohort of patients undergoing surgical and trans-catheter repair by means of Mitraclip implantation.\n\nMethods\n\n* Institutional database retrospective review for surgical mitral repair and MitraClip implantation.\n* Time frame: January 2012-December 2019\n* 2793 patients identified; Euroscore II 1.3% \\[0.6%-2%\\]\n* Survival after hospital discharge was assessed by outpatients visit, usually done 2 months after the index procedure.\n\nStatistical analysis\n\n* Receiver operating characteristic (ROC) curves were used to determine the cut-offs of Euroscore II. ROC Area Under the Curve (AUC) values varies between 0 and 1, where 0.5 denotes a bad diagnostic test and 1 denotes an excellent diagnostic test.\n* The maximum Youden's Index (J=sensitivity + specificity - 1) was employed to define the optimal cut-point.\n* ROC curves were repeated for surgical and MitraClip patients separately, and for primary and secondary etiology as well."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent surgical or transcatheter mitral valve repair', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undewent mitral valve repair with an open surgical approach, also in association with concomitant procedures (for example, but not limited to, aortic valve replacement, tricuspid repair, etc.)\n* Patients undergoing transcatheter mitral valve repair with MitraClip implantation\n* Patients operated on at the U.O. of Cardiac Surgery at the San Raffaele Hospital from January 2012 to December 2019\n\nExclusion Criteria:\n\n* Patients underwent mitral valve replacement with prosthesis\n* Cardiac surgery patients not eligible for mitral valve surgery\n* Patients undergoing mitral implantation, both open and transcatheter, of devices in experimental clinical study (e.g., but not limited to, adjustable rings and neocords, etc.)'}, 'identificationModule': {'nctId': 'NCT05714228', 'briefTitle': 'Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.', 'orgStudyIdInfo': {'id': 'VEOT-MVR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical repair', 'interventionNames': ['Procedure: Surgical Mitral Valve Repair']}, {'label': 'Transcatheter repair', 'interventionNames': ['Procedure: Transcatheter Mitral Valve Repair']}], 'interventions': [{'name': 'Surgical Mitral Valve Repair', 'type': 'PROCEDURE', 'description': 'Mitral valve is repaired using open surgical approach', 'armGroupLabels': ['Surgical repair']}, {'name': 'Transcatheter Mitral Valve Repair', 'type': 'PROCEDURE', 'description': 'Mitral valve is repaired using Mitraclip transcatheter device', 'armGroupLabels': ['Transcatheter repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michele De Bonis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of Cardiac Surgery of Advanced and Research Therapies', 'investigatorFullName': 'Michele De Bonis', 'investigatorAffiliation': 'Ospedale San Raffaele'}}}}