Collect patient data and to monitor the clinical use (safety and efficacy) of the device
Study Type
OBSERVATIONAL
Enrollment
144
Cardiovascular Department
Bergamo, Italy
Proper closure of the PVL (defined as Reduction in paravalvular regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.
Time frame: 6 month following implantation
Absence of device -and/or procedure-related Serious Adverse Events (SAEs) including deaths, stroke (ischemic stroke that occurs within 24 hours following implantation), systemic embolism or device embolizations.
Time frame: 6 month following implantation
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