RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve

Completed · Phase 2

Conditions studied: Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure

In brief

The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys 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.

Key facts

Study ID

NCT00120276

Run by

Myocor

People needed

250

Starts

2004-06-01

Last updated by the study team

2009-05-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• Prairie Research and Education Group — Springfield, Illinois, United States
• St. Joseph's Mercy Hospital — Ann Arbor, Michigan, United States
• Covenant Healthcare — Saginaw, Michigan, United States
• Nebraska Heart Institute — Lincoln, Nebraska, United States
• New York University — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Duke University — Durham, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• VA Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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