Mitral Valve Replacement With MValve Dock and Lotus
Mitral Valve Replacement With MValve Dock and Lotus
This study evaluates the MValve mitral prosthesis in conjunction with a Lotus transcatheter
 heart valve (THV) for mitral valve replacement in subjects at high risk for conventional
 mitral valve replacement or repair surgery.
This study is a prospective first in man feasibility study intended to evaluate preliminary
 safety and effectiveness of the MValve Mitral Dock with Lotus transcatheter heart valve for
 mitral valve replacement in subjects who are at high risk for surgical valve repair or
 replacement.

 The surgical technique adapts the valve-in-valve approach for mitral replacement in
 degenerated mitral prostheses to failing native mitral valves. The MValve Dock is designed to
 provide a structural platform within the mitral annulus so that the Lotus THV can be
 implanted in a secure fashion in the mitral annulus. The investigational device anchors to
 the mitral annulus commissures, sparing the native valve leaflets and sub annular apparatus.
 This study is designed to treat subjects with moderate-to-severe MR who are not deemed
 candidates for mitral valve surgery.
Inclusion Criteria:

 -  Symptomatic ≥3+ degenerative or functional mitral regurgitation of either ischemic or
 non-ischemic etiology based by a qualifying echocardiography obtained within 90 days
 prior to the procedure.

 -  New York Heart Association (NYHA) Functional Class III or IV.

 -  High risk for conventional open mitral valve repair or replacement surgery in the
 consideration of the site Heart Team.

 -  Left Ventricular Ejection Fraction (LVEF) is ≥30% within 30 days prior to the
 procedure.

 -  Mitral valve annular commissure to commissure (C/C) dimension between 30-35 mm by
 echocardiography.

 -  Left atrial diameter <5.5 cm by echocardiography

 Exclusion Criteria:

 -  Prior mitral valve replacement or repair surgery.

 -  Prior transapical surgery.

 -  Severe aortic or tricuspid valve disease. - Severe symptomatic carotid stenosis (>70%
 by ultrasound).

 -  ACC/AHA Stage D heart failure.

 -  Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or
 any other structural heart disease causing heart failure other than dilated
 cardiomyopathy of either ischemic or non-ischemic etiology.

 -  Infiltrative cardiomyopathies (amyloidosis, hemochromatosis, sarcoidosis).

 -  Physical evidence of right-sided congestive heart failure with echocardiographic
 evidence of moderate or severe right ventricular dysfunction.

 -  Severe mitral annular calcification.

 -  Glomerular filtration rate (GFR) < 30.

 -  Hemodynamic instability defined as systolic pressure < 90 mm Hg with or without
 afterload reduction, cardiogenic shock, or the need for inotropic support or
 intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart
 assistance.