Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
With
University of Pittsburgh
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Artificial Valve Endocarditis Reduction Trial
