Coronary Artery Disease - RESTOR-MV

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Trial Sponsor
Myocor

Principal Investigator
Carl Arentzen, MD

Trial Name
Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve (RESTOR-MV)

Purpose
The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys Annuloplasty System (Myocor, Inc.) to open surgical repair of the mitral valve using an annuloplasty ring or band in patients with moderate to severe functional mitral regurgitation.

Details
Patient clinical evaluations will consist of 3-month, 6-month, and 12- month follow up of the primary endpoints. Additional follow up of 18- month, 24-month, and annually thereafter will also be included.

Phase
Phase II

Study Type
Interventional

Study Design
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Arms
2

Expected Enrollment
250

Study Start
June 2004

Primary Outcome Measures

• Primary effectiveness endpoint to compare the mean change in MR grade in the Coapsys group to the open-heart annuloplasty group from baseline to 12 months.
• The primary safety endpoint is to compare the rate of primary adverse events (PAE's) through 12 months in the Coapsys group to the PAE rate in the open-heart annuloplasty group.

Secondary Outcome Measures

• Compare heart failure symptoms, left ventricular geometry, change in MR and TR, adverse events, and hospitalization time and costs of Coapsys group to control group

Eligibility

Ages Eligible for Study
18 – 80 years

Genders Eligible for Study
Both

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.

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