Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-02-26 @ 4:14 PM
Study NCT ID:
NCT01617720
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2012-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-29', 'studyFirstSubmitDate': '2012-06-07', 'studyFirstSubmitQcDate': '2012-06-10', 'lastUpdatePostDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• Ability of the Cardinal ring to reduce mitral valve regurgitation', 'timeFrame': '30 day'}, {'measure': '• Percentage of patients in whom the size of the ring is adjusted', 'timeFrame': '6 months'}, {'measure': '• Technical feasibility of adjustment.', 'timeFrame': '6 months', 'description': 'The ability of the surgeon to adjust the Cardinal ring when required, will be measured on a scale of 1-3 (1- successfull, 3- unsuccessful)'}, {'measure': '• The occurrence of serious device related adverse events in all patients.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mitral', 'valve', 'annuloplasty', 'mitral regurgitation'], 'conditions': ['Mitral Regurgitation']}, 'referencesModule': {'references': [{'pmid': '28012074', 'type': 'BACKGROUND', 'citation': 'Sundermann SH, Czesla M, Kempfert J, Walther T, Nataf P, Raanani E, Jacobs S, Alfieri O, Maisano F, Falk V. Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation. Heart Vessels. 2017 Jul;32(7):843-849. doi: 10.1007/s00380-016-0934-7. Epub 2016 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are candidate for mitral valve repair, with our without concomitant procedures.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Patient is a candidate for mitral valve repair, with our without concomitant procedures.\n* Subject is willing to give informed consent for collection of his/her clinical data.\n\nExclusion Criteria:\n\n* Severe organic lesions with retracted chordae\n* Congenital malformations with lack of valvular tissue\n* Severe valvular calcifications\n* Evolving bacterial endocarditis\n* Known Sensitivity to Nickel or Chromium'}, 'identificationModule': {'nctId': 'NCT01617720', 'acronym': 'MITRAFIT', 'briefTitle': 'MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Edwards Lifesciences'}, 'officialTitle': 'MITRAFIT Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)', 'orgStudyIdInfo': {'id': 'VC1-2'}}, 'contactsLocationsModule': {'locations': [{'zip': '70174', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'SANA Herzchirurgie', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Hospital San Rafaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Ottavio Alfieri, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital San Raffaele, Milan, Italy'}, {'name': 'Nicolas Doll, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SANA Herzchirurgie Stuttgart , Germany'}, {'name': 'Ehud Raanani, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}, {'name': 'Patrik Nataf, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bichat Hospital, Paris, France'}, {'name': 'Volkmar Falk, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zurich University, Zurich, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edwards Lifesciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}