Artificial Valve Endocarditis Reduction Trial
Stopped early · Not applicable
Conditions studied: Aortic Valve Disease, Mitral Valve Disease, Endocarditis
In brief
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
Key facts
- Study ID
- NCT00590889
- Run by
- Abbott Medical Devices
- People needed
- 807
- Starts
- 1998-07-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2019-02-27
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Florida Heart Group — Orlando, Florida, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham and Womens Hospital — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Sisters of Providence Health System — Portland, Oregon, United States
- Texas Heart Institute — Houston, Texas, United States
- LDS Hospital — Salt Lake City, Utah, United States
- University of Alberta Hospital — Edmonton, Alberta, Canada
- University of British Columbia — Vancouver, British Columbia, Canada
- Hôpital G. Et R. Laënnec — Nantes, France
- Deutches Herzzentrum Berlin — Berlin, Germany
- Fond Ne Centro S. Raffaele — Milan, Italy
- St. Antonius Ziekenhuis — Nieuwegein, Netherlands
- Hospital 12 de Octubre — Madrid, Spain
- Inselspital — Bern, Switzerland
- Hopital Regional-Service de Cardiologie — Sion, Switzerland
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.