Study Results
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View full resultsBasic Information
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TERMINATED
NA
807 participants
INTERVENTIONAL
1998-07-31
2014-09-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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St. Jude Medical (SJM) Conventional
St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff
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
Artificial Mechanical Heart Valve
Both arms used market released mechanical heart valves in accordance with approved labeling
Interventions
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Artificial Mechanical Heart Valve
Both arms used market released mechanical heart valves in accordance with approved labeling
Eligibility Criteria
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Inclusion Criteria
* 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 already has a prosthetic valve other than the valve being replaced at this time
* The patient requires a tricuspid valve replacement
ALL
No
Sponsors
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University of Pittsburgh
OTHER
Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Schaff H, Carrel T, Steckelberg JM, Grunkemeier GL, Holubkov R. Artificial Valve Endocarditis Reduction Trial (AVERT): protocol of a multicenter randomized trial. J Heart Valve Dis. 1999 Mar;8(2):131-9.
Davila-Roman VG, Waggoner AD, Kennard ED, Holubkov R, Jamieson WR, Englberger L, Carrel TP, Schaff HV; Artificial Valve Endocarditis Reduction Trial echocardiography study. Prevalence and severity of paravalvular regurgitation in the Artificial Valve Endocarditis Reduction Trial (AVERT) echocardiography study. J Am Coll Cardiol. 2004 Oct 6;44(7):1467-72. doi: 10.1016/j.jacc.2003.12.060.
Schaff HV, Carrel TP, Jamieson WR, Jones KW, Rufilanchas JJ, Cooley DA, Hetzer R, Stumpe F, Duveau D, Moseley P, van Boven WJ, Grunkemeier GL, Kennard ED, Holubkov R; Artificial Valve Endocarditis Reduction Trial. Paravalvular leak and other events in silzone-coated mechanical heart valves: a report from AVERT. Ann Thorac Surg. 2002 Mar;73(3):785-92. doi: 10.1016/s0003-4975(01)03442-7.
Englberger L, Carrel T, Schaff HV, Kennard ED, Holubkov R; AVERT Investigators. Differences in heart valve procedures between North American and European centers: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). J Heart Valve Dis. 2001 Sep;10(5):562-71.
Englberger L, Schaff HV, Jamieson WR, Kennard ED, Im KA, Holubkov R, Carrel TP; AVERT Investigators. Importance of implant technique on risk of major paravalvular leak (PVL) after St. Jude mechanical heart valve replacement: a report from the Artificial Valve Endocarditis Reduction Trial (AVERT). Eur J Cardiothorac Surg. 2005 Dec;28(6):838-43. doi: 10.1016/j.ejcts.2005.09.014. Epub 2005 Nov 7.
Other Identifiers
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979
Identifier Type: -
Identifier Source: org_study_id
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