Evaluation of the technical feasibility and safety of the Mitral Adjustable Annuloplasty Ring.
Establish the technical feasibility and safety of implantation of the investigation device, adjustment of the investigational device post-implantation, and the ability of the investigational device to reduce mitral valve regurgitation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
The investigational device is intended for use in the treatment of mitral valve regurgitation.
Herz - und Gefäß-Klinik GmbH Bad Neustadt
Bad Neustadt an der Saale, Saale, Germany
University Leipzig
Leipzig, Germany
Hospital San Raffaele
Milan, Italy
Leids Universitair Medisch Centrum
Leiden, Netherlands
Safety: Freedom from major adverse events (MAE)at 30 days. Performance: Technical success rate of implantation of the investigation device.
Time frame: 30 days, 90 days, 6 months and 1 year
Ability to adjust the investigational device post-ring implantation after the patient has been weaned from CPB. MR reduction to <2+ post procedure, at post operative hospital discharge, at 30 days, at 6 months and one year.
Time frame: 30 days, 90 days, 6 months and 1 year
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Erasmus MC, Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands