A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Annuloplasty ring applied in a transcatheter method
ZNA Middelheim Hospital
Antwerp, Belgium
Na Homolce Hospital
Prague, Czechia
Shaare Zedek Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Azienda Ospedaliera Di Padova
Safety - Freedom from major SAE's at 30 days following procedure
Freedom from major SAE's at 30 days following procedure
Time frame: 30 days
Technical success of implantation
Ring location and attachment based on echocardiography
Time frame: End of procedure
Safety - Freedom from major SAE's at 6 months following procedure
Freedom from major SAE's at 6 months following procedure
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Padua, Italy