Artificial Valve Endocarditis Reduction Trial (AVERT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00590889
First received: December 26, 2007
Last updated: January 17, 2014
Last verified: January 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Artificial Valve Endocarditis Reduction Trial

Resource links provided by NLM:


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: June 2014
Estimated Primary Completion Date: April 2014 (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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00590889     History of Changes
Other Study ID Numbers: 979
Study First Received: December 26, 2007
Last Updated: January 17, 2014
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

Additional relevant MeSH terms:
Endocarditis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014