Artificial Valve Endocarditis Reduction Trial
This trial is active, not recruiting.
|Conditions||aortic valve disease, mitral valve disease, endocarditis|
|Treatment||artificial mechanical heart valve|
|Sponsor||St. Jude Medical|
|Collaborator||University of Pittsburgh|
|Start date||July 1998|
|End date||April 2014|
|Trial size||804 participants|
|Trial identifier||NCT00590889, 979|
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.
|Intervention model||parallel assignment|
Incidence of artificial valve endocarditis based upon criteria published in Durack, et al, The American Journal of Medicine, March 1994, Volume 96:200-209.
time frame: Annually
All adverse events associated with valve implantation including, but not limited to: Bleeding events Embolism Endocarditis Nonstructural Dysfunction Structural Deterioration/Failure Valve Thrombosis Reoperation Death
time frame: Annually at follow-up visits
Male or female participants of any age.
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
|Official title||Artificial Valve Endocarditis Reduction Trial|
|Description||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.|
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