Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification

Inclusion criteria

• Heart Team determines subject is not a suitable candidate for conventional surgical treatment due to degree of MAC present and the subject will likely benefit from transcatheter valve implantation
• Symptomatic, severe mitral regurgitation, as defined in the 2017 ACC expert Consensus Decision Pathway on the Management of MR
• NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
• Age 18 years or older at time of consent
• Not a member of a vulnerable population per the investigator's judgment
• The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions, including complying with study required testing and follow-up visits, and has provided written informed consent

Exclusion criteria

• Presence of Left Ventricle or Left Atrium thrombus
• Chest condition that prevents transapical access
• Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram
• Left Ventricular End Diastolic Dimension (LVEDD) > 7.0 cm
• Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy
• Prior intervention with permanently implanted mitral device (e.g. MitraClip)
• Mitral pathoanatomy and Left Ventricular Outflow tract (LVOT) anatomy deemed not suitable for Tendyne mitral valve implantation
• Any planned cardiac surgery or intervention that is 30 days prior and 30 days post that is not concomitant with the Tendyne procedure
• Cardiac resynchronization therapy (CRT) device or implantable pulse generator (IPG) implanted within three months of planned implant procedure
• Myocardial Infarction (MI) within 30 days of the planned implant procedure
• Symptomatic, or ischemia-associated coronary artery disease (e.g., active ischemia) amenable to revascularization and thus requiring stenting or CABG
• Cerebrovascular accident (CVA) within six months of planned implant procedure
• Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound)
• Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support devices within 1 month prior to planned implant procedure
• Severe tricuspid regurgitation or severe right ventricular dysfunction
• Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology
• Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy if cannot be adequately treated
• History of endocarditis within 6 months of planned implant procedure
• Active systemic infection requiring antibiotic therapy
• Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anti-coagulation therapy) which cannot be adequately managed medically
• Subject unable or unwilling to take anticoagulation with warfarin for a minimum of 6 months following Tendyne valve implantation
• Known hypersensitivity to nickel or titanium
• Subject is undergoing hemodialysis due to chronic renal failure ( ≥ Stage 4 CKD)
• Subject has pulmonary arterial hypertension (fixed PAS >70mmHg)
• FEV1 < 50% of predicted or < 1L
• Subject refuses blood transfusions
• Subject has COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
• Pregnant, lactating, or planning pregnancy within next 12 months.
• Currently participating in an investigational drug or another device trial that has not reached its primary endpoint
• Subjects with non-cardiac co-morbidities that are likely to result in a life expectancy of less than 12 months