Prospective, observational, multi-center trial in which patients with mitral regurgitation sufficient to merit mitral valve repair will receive a surgical transvalvular, intra-annular Mitral Bridge™ to reduce or eliminate mitral regurgitation.
The primary objective of this study is to evaluate the safety and performance of the Mitral Bridge device in the correction of mitral valve regurgitation in patients who qualify for mitral valve repair as defined by the American Society of Echocardiography (ASE). The device is a single use, mitral valve implant designed to reduce mitral regurgitation by reducing the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane. The protocol was designed as a First In Man (FIM) with a 6-month follow up but was amended to follow the enrolled patients for a total of 5 years.
Study Type
OBSERVATIONAL
Enrollment
34
Surgical mitral valve implant intended to reduce mitral regurgitation by direct reduction of the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane
Na Homolce Hospital
Prague, Homolka, Czechia
Clinical Success
\- Freedom from subsequent open mitral valve repair or replacement
Time frame: One, 3, 6,12, 24, 36, 48, and 60 months
Preservation or improvement of left ventricular remodeling
Change in Left Ventricular status
Time frame: One, 3, 6,12, 24, 36, 48, and 60 months
Preservation of improvement in NYHA (New York Heart Association) functional class.
Change in NYHA (New York Heart Association) functional class.
Time frame: One, 3, 6,12, 24, 36, 48, and 60 months
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