Artificial Valve Endocarditis Reduction Trial

Abbott Medical Devices807 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

807

Conditions

Aortic Valve Disease Mitral Valve Disease Endocarditis

Interventions

Artificial Mechanical Heart ValveDEVICE

Both arms used market released mechanical heart valves in accordance with approved labeling

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (16)

Florida Heart Group

Orlando, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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