Degenerative Mitral Valve Disease Clinical Trial
Official title:
A Study to Assess the Effects of Two Commonly Used Mitral Valve Annuloplasty Rings in Mitral Valve Repair on Short-term Outcomes.
Recently published work has suggested that mitral valve annuloplasty ring type may affect the
development of post-repair mitral stenosis resulting in adverse intracardiac hemodynamics and
poor functional status. However, these results have not been comprehensively determined in a
systematic manner on a general mitral valve repair population. As well, an underlying
mechanism for these findings is not understood.
The investigators hypothesize that mitral valve repair with a complete annuloplasty ring
(Carpentier-Edwards Physio II) when compared to repair with a partial annuloplasty ring
(Simplici- T) may not necessarily result in elevated mitral gradients consistent with
functional mitral stenosis (FMS). Currently no prospective data exists to test the hypothesis
that a correctly sized, flexible complete annuloplasty ring has detrimental effects.
As 60% of annuloplasty rings used in surgical repair of degenerative mitral valve disease in
North America utilizes one of the many forms of complete flexible rings available, this
information is urgently required.
The investigators will evaluate: 1) the effect on mitral valve hemodynamics, 2) changes to
mitral annular, valvular and subvalvular structure and function with 3D echocardiography, and
3) the effect on patient functional capacity at 1 year.
If FMS early post repair is a real phenomenon, the investigators hope to better understand
the mechanisms through the use of advanced imaging techniques-namely 3D modeling of the
mitral valvular apparatus, aortic mitral interactions and LV remodeling.
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