Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study

Study Overview
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Brief Summary
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Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.

Detailed Description
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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.

Official Title
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Mitral Adjustable Annuloplasty Ring Feasibility and Safety Study (MAARS) for Treatment of Patients With Mitral Valve Regurgitation in Open Surgical Repair

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: Adjustable Annuloplasty Ring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Adjustable Annuloplasty Ring|The investigational device is intended for use in the treatment of mitral valve regurgitation.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device. |  | 30 days, 90 days, 6 months and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 30 days, 90 days, 6 months and 1 year |