Mitraclip device for patients with functional mitral regurgitation
Matthew J Price, M.D.
This study will evaluate the safety and effectiveness of the MitraClip device for treatment of mitral regurgitation (MR). The MitraClip procedure is only used to treat certain kinds of MR in people who are not candidates for surgery. Study participants will have follow-up visits at time of hospital discharge, 30 days, and 12 months, and will continue with follow-up visits according to standard of care for up to 5 years.
Have severe mitral regurgitation
Have tried all other reasonable options for treatment
Have had at least one hospitalization for heart failure in the past 12 months
Meet all other eligibility criteria
Have Chronic Obstructive Pulmonary Disease (COPD)
Have Transcatheter aortic valve replacement (TAVR) within the past 30 days
Have a Status 1 heart transplant
Have had a prior mitral valve leaflet surgery
The usual treatment for mitral regurgitation is an open heart surgical procedure to repair the leaflets of the valve by sewing them together. Additional measures may also be used, such as placing a ring around the mitral valve.
The MitraClip device functions the same as sewing the leaflets of the valve together, but without the need for open-heart surgery. All eligible patients who enroll in this study will receive the Mitraclip device.