Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

Procedure Safety (PS)

This will be assessed at exit from the procedure room and is defined as freedom from procedural mortality, unplanned surgical or interventional procedures related to the Tendyne valve or access procedure.

Time frame: Day 0, at exit procedure room

Freedom from LVOT Obstruction (LVOTO) at 30 Days

This will be assessed at 30 days post-procedure and is defined as mean LVOT gradient increase \<10 mmHg from baseline (measured by the Echo Core Lab), and free of unplanned intervention for LVOTO.

Time frame: At Day 30

Freedom from Paravalvular Leak (PVL) at 30 Days

This will be assessed at 30 days post-procedure and is defined as the Tendyne prosthesis PVL ≤ mild (Grade I), as measured by the Echo Core Lab.

Time frame: At Day 30

Left Ventricle Reverse Remodeling at 1 Year

This will be assessed at 1-year post-procedure and is defined as the proportion of survivors at one year with baseline Left Ventricle End Diastolic Volume Index (LVEDVi) \> 96ml/m2 that experience 10% or greater reduction in LVEDVi at one year (assessed by the Echo Core lab).

Time frame: At 1 Year

All-Cause Mortality at 30 Days

This will be assessed at 30 days post-procedure and is defined as the proportion of subjects who die within 30 days post-procedure for any cause.