Clinical Investigation for the Foldax Tria Mitral Valve- India

Clinical Investigation for the Foldax Tria Mitral Valve- India

The purpose of this study is to conduct a clinical investigation of the Foldax Tria Mitral Valve to collect evidence on the device's safety and performance.

The Foldax Tria Mitral Heart Valve is indicated as a replacement for diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. The study is a single open are label non-randomized multi- center clinical trial. Up to 10 sites in the country of India will enroll up to 70 patients. The first two patients at each site, will be considered roll-in patients accounting for training. Up to 50 patients will be considered part of the treatment phase. These patients will follow the study schedule for 1 year after implantation.

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.