The purpose of this study is to compare the safety and effectiveness of the Myocor Coapsys Annuloplasty System to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation.

Condition	Intervention	Phase
Mitral Valve Regurgitation	Device: Coapsys, implantable	Phase III

Further Study Details: 

Primary Outcomes: Effectiveness - MR grade reduction; Safety - Primary Adverse Events
Expected Total Enrollment:  250

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Grade 2, 3, or 4 functional mitral valve regurgitation per 2D echocardiography
• Patient undergoing concomitant coronary artery bypass graft surgery, either on-pump or off-pump
• Left ventricular ejection fraction greater than or equal to 25%
• Age between 18 and 80 years, inclusive
• Patient is willing and available to return for study follow up
• Ability of the patient or legal representative to understand and provide signed consent for participating in the study.

Exclusion Criteria:

• Structural abnormality of the mitral valve (e.g. calcification or thickening of the valve leaflets, ruptured papillary muscle, ruptured chordae tendinae, mitral valve prolapse, mitral stenosis, etc.)
• Asymptomatic Grade 2 MR (those with NYHA Class < II and LVEF > 40%)
• Organic valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring surgical intervention
• Transmural myocardial infarction within 30 day period prior to surgical placement of Coapsys
• NYHA class IV
• Left ventricular end diastolic diameter > 7.0 cm
• Cardiac surgery on an emergency or salvage basis
• Left atrial or left ventricular thrombus
• Left ventricular aneurysm
• Previous mitral valve surgery or other previous cardiac surgery that would preclude proper placement of the Coapsys
• Chronic renal failure requiring dialysis
• Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
• Active infection
• Life expectancy of less than 24 months due to conditions other than their cardiac status
• Participation in another investigational drug or device protocol
• Abnormal coronary or cardiac anatomy such that the device could not be placed without interfering with those anatomical structures.

Please refer to this study by ClinicalTrials.gov identifier  NCT00120276

Georgia
      St. Joseph''''s Hospital of Atlanta, Atlanta,  Georgia,  United States; Recruiting
Illinois
      Prairie Research and Education Group, Springfield,  Illinois,  United States; Recruiting
Michigan
      Covenant Healthcare, Saginaw,  Michigan,  United States; Recruiting
Nebraska
      Nebraska Heart Institute, Lincoln,  Nebraska,  United States; Recruiting
New York
      New York University, New York,  New York,  10016,  United States; Recruiting
      Lenox Hill Hospital, New York,  New York,  10021,  United States; Recruiting
North Carolina
      Duke University, Durham,  North Carolina,  27710,  United States; Recruiting
Oregon
      Northwest Surgical Associates, Portland,  Oregon,  United States; Recruiting
Pennsylvania
      Hospital of the University of Pennsylvania, Philadelphia,  Pennsylvania,  United States; Recruiting
      VA Pittsburgh, Pittsburgh,  Pennsylvania,  United States; Recruiting
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  United States; Recruiting

Study ID Numbers:  020202
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 15, 2005
ClinicalTrials.gov Identifier:  NCT00120276
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26