AVJ-514 Japan Trial

Inclusion criteria

• . Age 20 years or older.
• . Symptomatic moderate-to-severe (3+) or severe MR (4+) chronic Degenerative Mitral Regurgitation (DMR) or Functional Mitral Regurgitation (FMR) determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within180 days prior to subject registration, with MR severity based principally on the TTE study and confirmed by the Echocardiography Core Laboratory (ECL). The ECL may request a TEE.
• . Left Ventricular Ejection Fraction (LVEF) is ≥ 30％ within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI). Note: The method must provide a quantitative readout (not a visual assessment).
• . New York Heart Association (NYHA) classification is class II, class III, or ambulatory class IV.
• . Subject is deemed difficult for mitral valve surgery due to either Society of Thoracic Surgery (STS) surgical mortality risk for mitral valve replacement of ≥ 8% OR due to the presence of one of the following risk factors:
• . Mitral valve area ≥ 4.0 cm2 assessed by ECL based TTE within 90 days prior to subject registration. The ECL may request a TEE.
• . Left Ventricular End Systolic Dimension (LVESD) is ≤ 60mm assessed by site based on the TTE obtained within 90 days prior to subject registration.
• . The primary regurgitant jet is non-commissural based on TEE, and in the opinion of the AVJ-514 implanting investigator can successfully be treated by the AVJ-514. If a secondary jet exists, it must be considered clinically insignificant.