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Artificial Valve Endocarditis Reduction Trial

NCT00590889 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 807

Last updated 2019-02-27

Study results available
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Summary

The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).

Conditions

  • Aortic Valve Disease
  • Mitral Valve Disease
  • Endocarditis

Interventions

DEVICE

Artificial Mechanical Heart Valve

Both arms used market released mechanical heart valves in accordance with approved labeling

Sponsors & Collaborators

  • University of Pittsburgh

    collaborator OTHER

  • Abbott Medical Devices

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-07-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590889 on ClinicalTrials.gov