Artificial Valve Endocarditis Reduction Trial (AVERT)

February 1, 2019 updated by: Abbott Medical Devices
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

807

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.
Time Frame: 1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

January 10, 2008

First Posted (ESTIMATE)

January 11, 2008

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 979

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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