PARADIGM PARAvalvular Leak Closure With the Amplatzer Valvular Plug occluDer for Interventional Transcatheter Closure for PVL With Surgical bioloGical and Mechanical Heart Valve
The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position.
• 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