Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study

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.

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.