Evaluate the safety and efficacy of Medtronic Intrepid™ TMVR TF System in patients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC who, by agreement of the local site multidisciplinary heart team experienced in mitral valve therapies, are unsuitable for treatment with approved transcatheter repair or surgical mitral valve intervention.
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
Estimated life expectancy of less than 24 months
Currently surgically implanted mitral valve
Prior transcatheter mitral valve procedure with device currently implanted
Anatomic contraindications
Single group
Medtronic Intrepid™ TMVR TF System
DevicePatients with moderate-to-severe or severe symptomatic mitral regurgitation, or moderate symptomatic mitral regurgitation combined with mitral stenosis in the presence of MAC will have a Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR Transfemoral System
Safety: all-cause mortality at 1-year post-procedure.
Rate of all-cause mortality at 1-year post-procedure.
Efficacy: Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure.
Percentage of subjects with none/trace or mild mitral regurgitation at 30 days post-procedure as assessed by the Echocardiography Core Laboratory.
Rate of all-cause mortality (Safety).
Rate of all-cause mortality at 30 days post-procedure.
Disabling stroke (Safety).
Rate of disabling stroke at 30 days post-procedure.
Acute Kidney Injury (stage 3 or with renal replacement) (Safety).
Rate of acute kidney injury (stage 3 or with renal replacement) at 30 days post-procedure.
Reoperation or reintervention (Safety).
Rate of reoperation or reintervention at 30 days post-procedure.
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