Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-30 @ 10:56 PM
Study NCT ID:
NCT00554151
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2007-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2007-11-02', 'studyFirstSubmitQcDate': '2007-11-02', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device.', 'timeFrame': '30 days, 90 days, 6 months and 1 year'}], 'secondaryOutcomes': [{'measure': 'Ability to adjust the investigational device post-ring implantation after the patient has been weaned from CPB. MR reduction to <2+ post procedure, at post operative hospital discharge, at 30 days, at 6 months and one year.', 'timeFrame': '30 days, 90 days, 6 months and 1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mitral Valve Regurgitation']}, 'descriptionModule': {'briefSummary': 'Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.', 'detailedDescription': 'Establish the technical feasibility and safety of implantation of the investigation device, adjustment of the investigational device post-implantation, and the ability of the investigational device to reduce mitral valve regurgitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females aged greater or equal to 18 to less than or equal to age 75.\n* Patients with indications to undergo mitral valve repair consistent with ACC/AHA recommendations; including greater or equal to 2+ regurgitation by pre-operative TEE or TTE assessment.\n* Candidate for cardiopulmonary bypass.\n* A Left Ventricular Ejection Fraction greater or equal to 40%.\n* Able and willing to comply with all study requirements, including the required study follow-up visits.\n* Able and willing to five consent and follow study instructions.\n* Female patients of childbearing potential (not surgically sterilized or more than one year postmenopausal), with a negative pregnancy test (serum beta-hCG) within 24 hours prior to mitral valve surgery.\n\nExclusion Criteria:\n\n* Any previous cardiac surgery.\n* Any interventional cardiology procedure within six months prior to study to include all patients that have had a drug eluting stent (DES) implanted within 6 months.\n* Evidence of an acute Myocardial Infarction (MI) within 7 days of the intended treatment with the investigational device.\n* Prior mitral valve surgery or valvuloplasty or currently implanted prosthetic valve.\n* Restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2.\n* Recent or evolving bacterial endocarditis or patients under current antibiotic therapy.\n* Patients with ICD's.\n* Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the placement of the device or concurrent medical condition with a life expectancy of less than 12 months.\n* Patients who are immunocompromised or with autoimmune diseases.\n* Patients suffering from renal insufficiency (Creatinine \\>2.5 mg/dL) or patients with chronic renal failure undergoing dialysis.\n* Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. sever chronic obstructive pulmonary disease, hepatic failure, immunosuppressive abnormalities, haematological abnormalities).\n* Significant mitral annular calcification.\n* Use of Coumadin, IIbIIIa inhibitors, Clopidigrel (Plavix) or other anti-coagulants within (5) five days prior to surgery.\n* Participation in any study involving an investigational drug or device within the past month, or ongoing participation in a study with an investigational device.\n* Intolerance or hypersensitivity to anaesthetics.\n* Patients in whom transesophageal echo/Doppler is contraindicated.\n* History of bleeding diathesis or coagulopathy.\n* History of stroke within the prior 6 months\n* Subjects to undergo concomitant cardiac repair or replacement other than CABG (less than or equal to 3 vessels) mitral annuloplasty, tricuspid valve repair and ablation therapy for correction of atrial fibrillation. Excluded concomitant procedures are: aortic valve replacement, LV remodeling, surgery and congenital repair.\n* Patients with Euroscore \\> 10."}, 'identificationModule': {'nctId': 'NCT00554151', 'acronym': 'MAARS', 'briefTitle': 'Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS) for Treatment of Patients With Mitral Valve Regurgitation in Open Surgical Repair', 'orgStudyIdInfo': {'id': 'MAARS CIP Version 5'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Adjustable Annuloplasty Ring', 'type': 'DEVICE', 'description': 'The investigational device is intended for use in the treatment of mitral valve regurgitation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97615', 'city': 'Bad Neustadt an der Saale', 'state': 'Saale', 'country': 'Germany', 'facility': 'Herz - und Gefäß-Klinik GmbH Bad Neustadt', 'geoPoint': {'lat': 50.32174, 'lon': 10.20673}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'University Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Hospital San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leids Universitair Medisch Centrum', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC, Universitair Medisch Centrum Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'A. Franka Borger, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Leipzig Germany'}, {'name': 'A.P. Kappetein, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus MC, Universitair Medisch Centrum Rotterdam'}, {'name': 'R.J.M. Klautz, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leids Universitair Medisch Centrum Lieden'}, {'name': 'Anno Diegeler, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herz-und Gefäß-Klinik GmbH Bad Neustadt'}, {'name': 'Ottavio Alfieri, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital San Rafaele'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Vicki Bebeau', 'oldOrganization': 'St. Jude Medical, Inc.'}}}}