Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

Exclusion criteria

• ✕. Any stroke/TIA within 30 days
• ✕. Severe symptomatic carotid stenosis (\> 70% by non-invasive imaging)
• ✕. Active infections requiring antibiotic therapy
• ✕. Active ulcer or gastro-intestinal bleeding in the past 3 months
• ✕. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
• ✕. Patients in whom TEE is not feasible
• ✕. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
• ✕. Patient is unable to comply with the follow-up schedule and assessments