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
You may not be if
Estimated life expectancy of less than 24 months
Currently surgically implanted mitral valve
Prior transcatheter mitral valve procedure with device currently implanted
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
Clareo Health | Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
