Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

• Long term safety performance will be evaluated by comparing the linearized yearly rates listed below to the objective performance criteria (OPC) referenced in the Food and Drug Administration (FDA) 1994 Draft Heart Valve Guidance [ Time Frame: Entire study period (8 yrs post implant) ] [ Designated as safety issue: Yes ]
  a) Thromboembolism, b) All Hemorrhage, c) All Perivalvular Leak, d) Endocarditis
  
  

• Early rates, late linearized rates, and actuarial rates [ Time Frame: Entire study period (8 yrs post implant) ] [ Designated as safety issue: Yes ]
  Early rates, late linearized rates, and actuarial rates of: a) Thromboembolism b) Valve Thrombosis, c) All Hemorrhage, d) Major Hemorrhage, e) All Perivalvular leak, f) Major perivalvular leak, g) Endocarditis, h) Hemolysis, i) Structural valve deterioration, j) Non-structural valve dysfunction, k) Reoperation, l) Explant, m) Death, n) Valve Related death
  
  

This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant annually for a minimum of 8 years.