Artificial Valve Endocarditis Reduction Trial

The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces
the incidence of prosthetic valve endocarditis. The null and alternative hypotheses of this
study are:

- Ho: Patients receiving SJM Masters Series valves with Silzone coating will have an equal
incidence of PVE when compared to those receiving the conventional cuff.

- Ha: Patients receiving SJM Masters Series valves with Silzone coating will have a
reduced incidence of PVE when compared to those receiving the conventional cuff.

Inclusion Criteria:

- The patient requires an isolated mitral, isolated aortic, or double (aortic and
mitral) valve replacement

- The patient is a candidate to receive an SJM (St. Jude Medical) Masters Series
valve(s) with either the conventional cuff or the cuff with Silzone coating

- The patient (or legal guardian) has signed a study-specific consent form agreeing to
the randomization, data collection, and follow-up requirements

Exclusion Criteria:

- The patient has a medical condition which contraindicates implantation of the SJM
Masters Series with Silzone coating

- The patient already has a prosthetic valve other than the valve being replaced at this
time

- The patient requires a tricuspid valve replacement