To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,162
Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.
Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.
Heart-Center Dresden
Dresden, Saxony, Germany
RECRUITINGDeath from any cause and heart failure hospitalization
Composite endpoint of time to heart failure hospitalization or death from any cause
Time frame: 1 year
Death from any cause
Time from randomization to death from any cause
Time frame: 1, 2, 3, 4 years
Need for mitral valve reintervention
Need for mitral valve reintervention
Time frame: 1, 2, 3, 4 years
Mitral regurgitation severity
Mitral regurgitation severity at 12 months
Time frame: 1 year
6 Minute Walk Test
Change in 6 Minute Walk Test at 12 months
Time frame: 1 year
New York Heart Association Functional Class
Course of New York Heart Association (NYHA) Functional Class at 1, 3, 6 months and 1, 2, 3, 4 years
Time frame: 1, 3, 6 months and 1, 2, 3, 4 years
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