MitraClip device for patients at moderate risk for surgery
Matthew J Price, M.D.
The purpose of this research is to extend the current approved indication of the MitraClip device to include patients who are considered moderate-risk candidates for traditional mitral valve repair surgery.
Must be 18 years old or older
Must be at moderate surgical risk for mitral valve repair
Must have severe mitral regurgitation
Be willing to participate in the trial for 10 years
Patients must not:
Be currently participating in another clinical trial
Have secondary mitral regurgitation
Have severe tricuspid regurgitation or severe valve disease
Have had a heart attack in the last year
The MitraClip device is currently approved by the FDA for patients who are at high-risk for traditional surgery, but is not approved for patients considered moderate to low surgical risk.
All treatments and physician visits during this study will take place at Anderson Medical Pavilion, Scripps La Jolla. Study participation will last up to 10 years