Overview

This trial is active, not recruiting.

Conditions aortic valve disease, mitral valve disease, endocarditis
Treatment artificial mechanical heart valve
Phase phase 4
Sponsor St. Jude Medical
Collaborator University of Pittsburgh
Start date July 1998
End date April 2014
Trial size 804 participants
Trial identifier NCT00590889, 979

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Other)
SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff
artificial mechanical heart valve
Both arms used market released mechanical heart valves in accordance with approved labeling
(Other)
SJM Masters Series Mechanical Heart Valve with Silzone Coating
artificial mechanical heart valve
Both arms used market released mechanical heart valves in accordance with approved labeling

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by St. Jude Medical.