Artificial Valve Endocarditis Reduction Trial (AVERT)
Primary Purpose
Aortic Valve Disease, Mitral Valve Disease, Endocarditis
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Artificial Mechanical Heart Valve
Sponsored by
About this trial
This is an interventional prevention trial for Aortic Valve Disease focused on measuring artificial heart valve, mitral heart valve, aortic heart valve, endocarditis, Aortic valve disease requiring replacement, Mitral valve disease requiring replacement
Eligibility 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
Sites / Locations
- Florida Heart Group
- Massachusetts General Hospital
- Brigham and Womens Hospital
- Mayo Clinic
- Sisters of Providence Health System
- Texas Heart Institute
- LDS Hospital
- University of Alberta Hospital
- University of British Columbia
- Hôpital G. Et R. Laënnec
- Deutches Herzzentrum Berlin
- Fond Ne Centro S. Raffaele
- St. Antonius Ziekenhuis
- Hospital 12 de Octubre
- Inselspital
- Hopital Regional-Service de Cardiologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
St. Jude Medical (SJM) Conventional
St. Jude Medical (SJM) Silzone
Arm Description
St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff
St. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating
Outcomes
Primary Outcome Measures
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00590889
First Posted
December 26, 2007
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
Collaborators
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00590889
Brief Title
Artificial Valve Endocarditis Reduction Trial
Acronym
AVERT
Official Title
Artificial Valve Endocarditis Reduction Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
July 1998 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
Collaborators
University of Pittsburgh
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate whether the Silzone coated sewing cuff reduces the incidence of prosthetic valve endocarditis (PVE).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Mitral Valve Disease, Endocarditis
Keywords
artificial heart valve, mitral heart valve, aortic heart valve, endocarditis, Aortic valve disease requiring replacement, Mitral valve disease requiring replacement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
807 (Actual)
8. Arms, Groups, and Interventions
Arm Title
St. Jude Medical (SJM) Conventional
Arm Type
Other
Arm Description
St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff
Arm Title
St. Jude Medical (SJM) Silzone
Arm Type
Other
Arm Description
St. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating
Intervention Type
Device
Intervention Name(s)
Artificial Mechanical Heart Valve
Intervention Description
Both arms used market released mechanical heart valves in accordance with approved labeling
Primary Outcome Measure Information:
Title
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.
Description
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.
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Florida Heart Group
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Sisters of Providence Health System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Hôpital G. Et R. Laënnec
City
Nantes
Country
France
Facility Name
Deutches Herzzentrum Berlin
City
Berlin
Country
Germany
Facility Name
Fond Ne Centro S. Raffaele
City
Milan
Country
Italy
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
Country
Netherlands
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Hopital Regional-Service de Cardiologie
City
Sion
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
10224570
Citation
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.
Results Reference
background
PubMed Identifier
15464329
Citation
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.
Results Reference
result
PubMed Identifier
11899956
Citation
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.
Results Reference
result
PubMed Identifier
11603594
Citation
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.
Results Reference
result
PubMed Identifier
16275007
Citation
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.
Results Reference
result
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Artificial Valve Endocarditis Reduction Trial
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