PARADIGM: Amplatzer Valvular Plug for PVL Closure

Inclusion Criteria:

• Subject is implanted with a mechanical or biological surgical valve in the aortic ormitral position

• Note: Subjects in European countries can only be implanted with a mechanical valvein the aortic or mitral position

• Subject has a clinically significant paravalvular leak with a severity grade ofmoderate or higher, associated with signs of heart failure and/or hemolysisnecessitating recurring blood transfusions.

• Subject has one clinically significant PVL defect that can be closed with a singleAVP 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 involvingmore 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 aclinically 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 AVP III (such as a PVLassociated with an abscess cavity or a pseudoaneurysmal sac) or anatomy where theAVP III would interfere with other intracardiac or intravascular structures (suchcoronary ostia)

• Subjects who are unable to receive intraprocedural anticoagulant therapy

• Pregnant or nursing subjects or subjects who plan pregnancy during the clinicalinvestigation follow-up period.

• Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results.

• Life expectancy is less than 1 year in the opinion of the Investigator

• Incapacitated individuals, defined as persons with mental illnesses or handicapsthat impair their ability to provide informed consent, or individuals without legalauthority to provide informed consent.

• Individual who are currently participating in an investigational drug or devicestudy that has not reached the primary endpoint or that may confound the results ofthis study