Artificial Valve Endocarditis Reduction Trial (AVERT)

Abbott

Status

Terminated

Conditions

Mitral Valve Disease

Endocarditis

Aortic Valve Disease

Treatments

Device: Artificial Mechanical Heart Valve

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00590889

979

Details and patient eligibility

About

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

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

Enrollment

807 patients

Sex

All

Volunteers

No Healthy Volunteers

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