Mitral Valve Replacement With MValve Dock and Lotus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mitral Valve Replacement With the MValve Dock and A Percutaneous Transcatheter Heart Valve

Conditions
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Mitral Valve Regurgitation

Intervention / Treatment
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* Device: mitral valve replacement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Valve Replacement<br>Mitral valve replacement | Device: mitral valve replacement<br>* transcatheter mitral valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite serious adverse cardiac events and stroke | death, myocardial infarction, stroke, repeat surgery | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitral regurgitation grade |  | 1 year |