Collect patient data and to monitor the clinical use (safety and efficacy) of the device
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Timeframe: 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.
Timeframe: 6 month following implantation