PARADIGM: Amplatzer Valvular Plug for PVL Closure

Inclusion Criteria: * Subject is implanted with a mechanical or biological surgical valve in the aortic or mitral position * Note: Subjects in European countries can only be implanted with a mechanical valve in the aortic or mitral position * Subject has a clinically significant paravalvular leak with a severity grade of moderate or higher, associated with signs of heart failure and/or hemolysis necessitating recurring blood transfusions. * Subject has one clinically significant PVL defect that can be closed with a single AVP III as assessed pre-procedurally * Subject has provided written informed consent * Subject is ≥18 years old Exclusion Criteria: * Subject has a rocking valve or extreme dehiscence of the prosthetic valve involving more than 40% of the sewing ring * Subject's PVL(s) originates from a transcatheter aortic or mitral valve replacement, or from rapid deployment or sutureless surgical replacement valves * Subject has a prosthetic aortic valve and prosthetic mitral valve which both have a clinically significant paravalvular leak. * Subject who is hemodynamically unstable or who cannot undergo an elective procedure * Subject with active endocarditis or other active infection * Subject has within the last 6 months a previously documented intracardiac mass, vegetation, tumor, or thrombus which would interfere with placement of the AVP III * Subject has inadequate vasculature for delivery of the AVP III * Subject has unsuitable anatomy for PVL closure using the …