This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
mitral valve repair due to mitral degenerative or functional disease
University of Heidelberg
Heidelberg, Germany
Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative).
Time frame: 6 months
NYHA class
Time frame: 6 months
adverse events rates
Time frame: 6 months
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