Artificial Valve Endocarditis Reduction Trial - Full Text View

Sponsors and Collaborators:	St. Jude Medical University of Pittsburgh
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00590889

Purpose

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.

Condition	Intervention	Phase
Aortic Valve Disease Mitral Valve Disease Endocarditis	Device: Artificial Mechanical Heart Valve	Phase IV

MedlinePlus related topics: Endocarditis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment
Official Title:	Artificial Valve Endocarditis Reduction Trial

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	804
Study Start Date:	July 1998
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SJM Conventional SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff	Device: Artificial Mechanical Heart Valve Both arms used market released mechanical heart valves in accordance with approved labeling
SJM Silzone SJM Masters Series Mechanical Heart Valve with Silzone Coating	Device: Artificial Mechanical Heart Valve Both arms used market released mechanical heart valves in accordance with approved labeling

Detailed 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590889

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

St. Jude Medical

University of Pittsburgh

More Information

Responsible Party:	St. Jude Medical, Inc. ( Alan Flory, DVM )
Study ID Numbers:	979
Study First Received:	December 26, 2007
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00590889
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Medical:

artificial heart valve
mitral heart valve
aortic heart valve

endocarditis
Aortic valve disease requiring replacement
Mitral valve disease requiring replacement

Study placed in the following topic categories:

Heart Diseases
Heart Valve Diseases
Endocarditis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009