Artificial Valve Endocarditis Reduction Trial

Aortic Valve Disease Clinical Trial

— AVERT  

Official title:

Artificial Valve Endocarditis Reduction Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00590889
• Other study ID #: 979
• Status: Terminated
• Phase: N/A
• Start date: July 1998
• Est. completion date: September 2014

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 807
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease
• Endocarditis
• Heart Defects, Congenital
• Heart Valve Diseases
• Mitral Valve Disease

Intervention

Device:
• Artificial Mechanical Heart Valve
Both arms used market released mechanical heart valves in accordance with approved labeling

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	University of Pittsburgh

Countries where clinical trial is conducted

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

References & Publications (5)

Dávila-Román 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 Endo — View 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. — View 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 V — View 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. — View 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 sil — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year