Trial record 2 of 87 for:    endocarditis

Artificial Valve Endocarditis Reduction Trial (AVERT)

This study has been terminated.
(A post-PMA begun in 1998; enrollment halted in 2000 due to an anomaly in one study arm. The protocol required annual study visits after 2000.)
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00590889
First received: December 26, 2007
Last updated: November 18, 2015
Last verified: November 2015
  Purpose
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).

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

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 Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 807
Study Start Date: July 1998
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
St. Jude Medical (SJM) Conventional
St. Jude Medical (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
St. Jude Medical (SJM) Silzone
St. Jude Medical (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 Masters Series valves with Silzone coating will have a reduced incidence of PVE when compared to those receiving the conventional cuff.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
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 (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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Florida Heart Group
Orlando, Florida, United States, 32803
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, Oregon
Sisters of Providence Health System
Portland, Oregon, United States, 97225
United States, Texas
Texas Heart Institute
Houston, Texas, United States, 77030
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84103
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
France
Hôpital G. Et R. Laënnec
Nantes, France
Germany
Deutches Herzzentrum Berlin
Berlin, Germany
Italy
Fond Ne Centro S. Raffaele
Milan, Italy
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Spain
Hospital 12 de Octubre
Madrid, Spain
Switzerland
Inselspital
Bern, Switzerland, CH-3010
Hopital Regional-Service de Cardiologie
Sion, Switzerland
Sponsors and Collaborators
St. Jude Medical
University of Pittsburgh
  More Information

Publications:

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00590889     History of Changes
Other Study ID Numbers: 979 
Study First Received: December 26, 2007
Results First Received: June 22, 2015
Last Updated: November 18, 2015
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 Defects, Congenital
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2016