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 definedby the American Society of Echocardiography 2017 Guidelines and Standards -Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, orsubject has moderate symptomatic mitral regurgitation combined with mitral stenosiswith the presence of MAC

• Local site multidisciplinary heart team experienced in mitral valve therapies agreesthat patient is unsuitable for treatment with approved transcatheter repair orconventional mitral valve surgery

• Subject and the treating physician agree that the subject will return for allrequired post-procedure follow-up visits

• Subject meets the legal minimum age to provide informed consent based on localregulatory 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 daysof enrollment

• LVEF < 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25

• <30% will be further evaluated by the Screening Committee for approval (RightVentricular 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