Artificial Valve Endocarditis Reduction Trial

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).

Detailed Description
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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.

Official Title
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Artificial Valve Endocarditis Reduction Trial

Conditions
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Aortic Valve Disease, Mitral Valve Disease, Endocarditis

Intervention / Treatment
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* Device: Artificial Mechanical Heart Valve


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: St. Jude Medical (SJM) Conventional<br>St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff | Device: Artificial Mechanical Heart Valve<br>* Both arms used market released mechanical heart valves in accordance with approved labeling<br>|
| Other: St. Jude Medical (SJM) Silzone<br>St. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating | Device: Artificial Mechanical Heart Valve<br>* Both arms used market released mechanical heart valves in accordance with approved labeling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves. | Patient response to treatment with the Silzone™ treated valve will be evaluated based upon the incidence of early and late PVE (prosthetic valve endocarditis) in the treatment group vs. the control group. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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artificial heart valve, mitral heart valve, aortic heart valve, endocarditis, Aortic valve disease requiring replacement, Mitral valve disease requiring replacement