Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS)

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00554151
First received: November 2, 2007
Last updated: June 20, 2011
Last verified: February 2010

November 2, 2007
June 20, 2011
July 2007
March 2009   (final data collection date for primary outcome measure)
Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device. [ Time Frame: 30 days, 90 days, 6 months and 1 year ] [ Designated as safety issue: Yes ]
Safety: Freedom from major adverse events (MAE). Performance: Technical success rate of implantation of the investigation device. [ Time Frame: 30 days, 90 days, and 6 months ]
Complete list of historical versions of study NCT00554151 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 30 days, 90 days, 6 months and 1 year ] [ Designated as safety issue: Yes ]
- Ability to adjust the investigational device post-ring implantation after the patient has been weaned from CPB. - MR reduction post-procedure at post-operative hospital discharge [ Time Frame: 30 days, 90 days, and 6 months ]
Not Provided
Not Provided
 
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study
Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS) for Treatment of Patients With Mitral Valve Regurgitation in Open Surgical Repair

Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mitral Valve Regurgitation
Device: Adjustable Annuloplasty Ring
The investigational device is intended for use in the treatment of mitral valve regurgitation.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
April 2010
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or females aged greater or equal to 18 to less than or equal to age 75.
  • 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.
  • Candidate for cardiopulmonary bypass.
  • A Left Ventricular Ejection Fraction greater or equal to 40%.
  • Able and willing to comply with all study requirements, including the required study follow-up visits.
  • Able and willing to five consent and follow study instructions.
  • 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.

Exclusion Criteria:

  • Any previous cardiac surgery.
  • 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.
  • Evidence of an acute Myocardial Infarction (MI) within 7 days of the intended treatment with the investigational device.
  • Prior mitral valve surgery or valvuloplasty or currently implanted prosthetic valve.
  • Restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2.
  • Recent or evolving bacterial endocarditis or patients under current antibiotic therapy.
  • Patients with ICD's.
  • 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.
  • Patients who are immunocompromised or with autoimmune diseases.
  • Patients suffering from renal insufficiency (Creatinine >2.5 mg/dL) or patients with chronic renal failure undergoing dialysis.
  • 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).
  • Significant mitral annular calcification.
  • Use of Coumadin, IIbIIIa inhibitors, Clopidigrel (Plavix) or other anti-coagulants within (5) five days prior to surgery.
  • Participation in any study involving an investigational drug or device within the past month, or ongoing participation in a study with an investigational device.
  • Intolerance or hypersensitivity to anaesthetics.
  • Patients in whom transesophageal echo/Doppler is contraindicated.
  • History of bleeding diathesis or coagulopathy.
  • History of stroke within the prior 6 months
  • 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.
  • Patients with Euroscore > 10.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Netherlands
 
NCT00554151
MAARS CIP Version 5
Yes
Vicki Bebeau, St. Jude Medical, Inc.
St. Jude Medical
Not Provided
Principal Investigator: A. Franka Borger, Prof. MD University Leipzig Germany
Principal Investigator: A.P. Kappetein, Dr. Erasmus MC, Universitair Medisch Centrum Rotterdam
Principal Investigator: R.J.M. Klautz, Dr. Leids Universitair Medisch Centrum Lieden
Principal Investigator: Anno Diegeler, Prof, MD Herz-und Gefäß-Klinik GmbH Bad Neustadt
Principal Investigator: Ottavio Alfieri, Prof, MD Hospital San Rafaele
St. Jude Medical
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP