Clinical Investigation for the Foldax Tria Mitral Valve- India

Inclusion Criteria: * Is 18 years or older * Is a candidate for mitral valve replacement with cardiopulmonary bypass * Is a candidate for mitral valve replacement due to severe mitral valve disease * No contraindication for anticoagulation treatment * Willing and able to comply with protocol requirements Exclusion Criteria: * Requires valve replacement other than mitral * Prior mitral valve surgery for valve replacement or valve repair (this does NOT include percutaneous interventions i.e. Mitraclip, chordal replacement) * Required concomitant cardiovascular procedures except for CABG and/or COX-MAZE if approved by the screening committee * Requires emergency surgery * Requires other planned surgery within 12 months of valve replacement * Active endocarditis or active myocarditis * Exhibits left ventricular ejection fraction \</= 20% as validated by diagnostic procedure prior to planned valve surgery * Acute preoperative neurological deficit defined as neurological deficit \< 3 months prior to enrollment * Life expectancy of less than 12 months * Enrolled in another investigational device or drug study (enrolled patients may not enroll in other studies) * Myocardial infarction, or severe cardiac adverse event which has not returned to baseline for at least 30-days prior to enrollment * Aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complications * Renal insufficiency as determined by creatinine (S-CR) level as \>/= 2.0 mg/dl or end stage renal disease requiring chronic dialysis at screening visit * Results for the following blood tests are not within normal limits: D-Dimer, Basic Metabolic Panel Liver enzymes, Coagulation Profile - platelets, APTT, INR, Fibrinogen, C-reactive protein (HSCRP) and ESR, and Troponin levels * Hematological disorders, patients must not have a hematocrit of \<30%, hemoglobin \<10 g/dL, platelet count of \<100,000 cells/µL, or WBC \<4,000 cells/µL; coagulation profile must not be outside of normal limits * Patients who are pregnant or expect to become pregnant in the 12 months following implantation, or are lactating * Any other condition that, in the judgment of the investigator and screening committee, makes the patient a poor candidate for the procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, COVID-19 related concerns) * Patients who have withdrawn after implantation may not re-enter * Intraoperatively it is determined that the patient anatomy is not compatible with the device.