Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the Model 400 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease
To evaluate the safety and effectiveness of the Model 400 aortic valve bioprosthesis with regard to valve-related adverse events and death. The following valve-related adverse events will be evaluated in this study: Thromboembolism, Thrombosis, Hemorrhage, Paravalvular leak (PVL), Endocarditis, Hemolysis, Structural valve deterioration, Non-structural dysfunction, Reintervention, Explant, and Death.
Are you Eligible? (Inclusion Criteria)
Patients with moderate or severe aortic stenosis or regurgitation who will undergo replacement of their native or prosthetic aortic valve with a bioprosthesis.