Expired Study
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Rochester, Minnesota 55905


Purpose:

The purpose of this study is to determine if post operative endocarditis differ significantly between the St. Jude Medical mechanical heart valve with and without Silzone(TM) coating.


Study summary:

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 Masers Series valves with Silzone coating will have a reduced incidence of PVE when compared to those receiving the conventional cuff.


Criteria:

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 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


NCT ID:

NCT00590889


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Rochester, Minnesota 55905
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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