Status:
COMPLETED
RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
Lead Sponsor:
Myocor
Conditions:
Mitral Valve Regurgitation
Left Ventricular Dysfunction
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
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 include...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00120276
Start Date
June 1 2004
Last Update
May 7 2009
Active Locations (10)
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1
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
2
Prairie Research and Education Group
Springfield, Illinois, United States
3
St. Joseph's Mercy Hospital
Ann Arbor, Michigan, United States
4
Covenant Healthcare
Saginaw, Michigan, United States