The safety and effectiveness of the SAPIEN 3 and SAPIEN 3 Ultra valve with Commander delivery system in patients with symptomatic severe calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.

10824MITRAL2-NCT04408430OpenThe safety and effectiveness of the SAPIEN 3 and SAPIEN 3 Ultra valve with Commander delivery system in patients with symptomatic severe calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.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.NCT04408430OtherAdultTreatmentDevice: Transseptal ViMACII/IIIDiseases Of The Circulatory SystemThis study investigates the following conditions or diseases: Mitral Annular Calcification Mitral Stenosis Mitral Regurgitation Mitral Valve DiseaseSatler, LowellMedstar Washington Hospital CenterMCRN - Wash Interventional2026.1.0 Build 16 <a href="https://advarra.com" target="_blank">© 2026 Advarra, Inc.</a>