Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-31 @ 1:16 AM
Study NCT ID:
NCT01112566
Status:
COMPLETED
Last Update Posted:
2018-04-26
First Post:
2010-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Saudi Arabia', 'United Kingdom']}, '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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-25', 'studyFirstSubmitDate': '2010-04-27', 'studyFirstSubmitQcDate': '2010-04-27', 'lastUpdatePostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify the patient population for which a Profile 3D Annuloplasty Ring is chosen to repair the mitral valve insufficiency.', 'timeFrame': 'screening'}, {'measure': 'Assess the percentage of patients that are chronically relieved from mitral valve dysfunction', 'timeFrame': '6-12 months follow up'}, {'measure': 'Determine the level of mitral valve regurgitation in patients', 'timeFrame': '6-12 months post-surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mitral Valve Insufficiency']}, 'referencesModule': {'references': [{'pmid': '29931248', 'type': 'DERIVED', 'citation': 'Doll N, Sheytanov V, Labrousse L, Chu MWA, Stefano P, Mokracek A, Baron O, Li S, Gunzinger R. Clinical performance of a three-dimensional saddle-shaped, rigid ring for mitral valve repair. Eur J Cardiothorac Surg. 2019 Feb 1;55(2):217-223. doi: 10.1093/ejcts/ezy215.'}], 'seeAlsoLinks': [{'url': 'http://www.medtronic.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The goal of the study is to identify the patients suffering from a mitral valve condition who benefit from the implantation of a Profile 3D annuloplasty ring in terms of acute and long-term relief of mitral valve regurgitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patient population includes all patients suffering from mitral valve disease, indicated for a mitral valve repair procedure, either as a stand-alone procedure or concomitant to a coronary artery bypass grafting, an aortic replacement or tricuspid valve repair and/or the treatment of atrial fibrillation, and for which the surgeon considers the implantation of a Profile 3D annuloplasty product most appropriate to reconstruct the regurgitant valve.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indicated for a surgical repair for moderate to severe mitral valve regurgitation at rest (level 2 or higher);\n* Willing to return to the hospital where the implantation originally occurred as part of the standard practice of care\n\nExclusion Criteria:\n\n* Heavily calcified valves\n* Valvular retraction with severely reduced mobility\n* Active bacterial endocarditis\n* Already participating in another investigational device study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints;\n* Life expectancy of less than one year;\n* Pregnant or desire to be pregnant within 12 months of the study treatment;\n* Under 18 years or over 85 years of age.'}, 'identificationModule': {'nctId': 'NCT01112566', 'briefTitle': 'EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiovascular'}, 'officialTitle': 'EASE MITRAL Expertise-based Assessment Study on Clinical Efficacy of Profile 3D in MITRAL Valve Annuloplasty', 'orgStudyIdInfo': {'id': 'BRC-CS-2010-03'}}, 'contactsLocationsModule': {'locations': [{'zip': 'ON N6G 2V4', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre, University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '37001', 'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Nemocnice Ceske Budejovice A.S.', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '33604', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Hôpital Haut - Leveque - CHU Pessac Cedex Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '44800', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes - Hôpital Nord Laennec', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '80636', 'city': 'München', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '70174', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'SANA Herzchirurgie Stuttgart GmbH', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}