Heart Failure Clinical Trial
Official title:
Safety and Efficacy of Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
Device under Test: The Viacor® Percutaneous Transvenous Mitral Annuloplasty (PTMA) system
comprises a sterile implantable cardiac device and associated custom accessories to assist
implantation. The PTMA system is intended to treat functional mitral regurgitation (MR) in a
heart failure patient by a less invasive method than surgical annuloplasty with greater
relief of symptoms than medical management alone.
Study Objective: Functional mitral regurgitation is associated with an adverse prognosis in
the heart failure patient. The objective of this study is to evaluate whether PTMA is
effective in reducing mitral regurgitation in heart failure patients and whether this
reduction is associated with a moderation in the adverse progression of heart failure
symptoms.
Hypothesis under Test: Reduction of the severity of functional mitral regurgitation from
baseline, as defined by a composite improvement of quantitative echocardiographic metrics,
can be achieved safely with the PTMA device and will be associated with a measurable
moderation of adverse progression of heart failure symptoms and a moderation of the
deterioration of exercise capacity.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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