Patient Eligibility THE APOLLO TRIAL

CAUTION: Investigational device. Limited by United States law to investigational use. Exclusively for Clinical Investigations.

Eligibility

The following outlines inclusion and exclusion criteria for the APOLLO Trial.

Key Inclusion Criteria

Randomized Cohort and Single-arm Cohort:

• Subject has moderate to severe or severe symptomatic mitral regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of mitral annular calcification (MAC, for the MAC cohort only).
• Heart team agrees that patient is a candidate for bioprosthetic mitral valve replacement

Key Exclusion Criteria

Randomized Cohort:

• Subject has comorbidities such that the Heart Team agrees predicted risk of operative mortality is <3% at 30 days or has ≥35% risk of mortality or irreversible major morbidity at 30 days
• Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions
• Subject with mitral anatomy that would preclude management of the sub-valvular apparatus and/or full chordal sparing
• Prior mitral valve surgery including previously implanted mitral valve, ring, or band

Single-arm Cohort:

• Subject has comorbidities such that the Heart Team agrees predicted risk of operative mortality or irreversible major morbidity is <35% or ≥ 50% at 30 days
• Currently implanted mitral valve
• Estimated life expectancy of less than 12 months due to associated non-cardiac comorbid conditions

Additional Exclusion Criteria
(All Cohorts):

• Prior transcatheter mitral valve procedure with device currently implanted
• Anatomic contraindications for Intrepid™ TMVR System (eg, annular dimensions, high risk of LVOT obstruction, transapical access, etc.)
• Anatomically prohibitive mitral annular calcification (MAC)
• Left ventricular ejection fraction (LVEF) <25%, or LVEF 25-30% in the presence of left ventricular end diastolic volume index (LVEDVi) >120mL/m²
• Hemodynamic instability requiring dependency of either inotropic agents or mechanical circulatory support
• Need for emergent or urgent surgery