Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial

Inclusion Criteria: * Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC * Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery * Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits * Subject meets the legal minimum age to provide informed consent based on local regulatory requirements * Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System Exclusion Criteria: * Estimated life expectancy of less than 24 months * Currently surgically implanted mitral valve * Prior transcatheter mitral valve procedure with device currently implanted * Anatomic contraindications * Anatomically prohibitive mitral annular calcification (MAC) * Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment * LVEF \< 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - \<30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function) * Left ventricular end diastolic diameter (LVEDD) \> 75mm * Need for emergent or urgent surgery * Hemodynamic instability * History of bleeding diathesis or coagulopathy * End stage renal disease * Liver failure * Frailty