STUDY OBJECTIVE~The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.~STUDY DESIGN~A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease. There are 2 arms in this study: Transseptal Valve-in-MAC (ViMAC) and a control arm of patients treated with medical treatment only which will include patients who can't be treated due to the presence of anatomical exclusion criteria or other exclusion criteria.~Enrollment Enrollment will consist of 110 patients in the treatment arm (transseptal ViMAC) and up to 100 in the medically treated arm).
A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease. There are 2 arms in this study: Transseptal Valve-in-MAC (ViMAC) and a control arm of patients treated with medical treatment only which will include patients who can't be treated due to the presence of anatomical exclusion criteria or other exclusion criteria.