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

Prospective, single-arm, multi-center, interventional, pre-market 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