NCT00590889

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
807

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 1998

Longer than P75 for not_applicable

Geographic Reach
8 countries

16 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 22, 2015

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

16.2 years

First QC Date

December 26, 2007

Results QC Date

June 22, 2015

Last Update Submit

February 1, 2019

Conditions

Aortic Valve DiseaseMitral Valve DiseaseEndocarditis

Keywords

artificial heart valvemitral heart valveaortic heart valveendocarditisAortic valve disease requiring replacementMitral valve disease requiring replacement

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

St. Jude Medical (SJM) Conventional

OTHER

St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff

Device: Artificial Mechanical Heart Valve

St. Jude Medical (SJM) Silzone

OTHER

St. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating

Device: Artificial Mechanical Heart Valve

Interventions

Artificial Mechanical Heart ValveDEVICE

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

St. Jude Medical (SJM) ConventionalSt. Jude Medical (SJM) Silzone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Florida Heart Group

Orlando, Florida, 32803, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Sisters of Providence Health System

Portland, Oregon, 97225, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

LDS Hospital

Salt Lake City, Utah, 84103, United States

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

Hôpital G. Et R. Laënnec

Nantes, France

Location

Deutches Herzzentrum Berlin

Berlin, Germany

Location

Fond Ne Centro S. Raffaele

Milan, Italy

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Inselspital

Bern, CH-3010, Switzerland

Location

Hopital Regional-Service de Cardiologie

Sion, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 10224570BACKGROUND

  • 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.

    PMID: 15464329RESULT

  • 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.

    PMID: 11899956RESULT

  • 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.

    PMID: 11603594RESULT

  • 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.

    PMID: 16275007RESULT

MeSH Terms

Conditions

Aortic Valve DiseaseEndocarditis

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Limitations and Caveats

This study was terminated early. No final report was created.

Results Point of Contact

Title
Heidi Hinrichs, VP of Clinical Study Management, St. Jude Medical
Organization
St.Jude Medical
hhinrichs@sjm.com

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

July 1, 1998

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 27, 2019

Results First Posted

December 22, 2015

Record last verified: 2019-02

Locations

FR(1)NL(1)CA(2)IT(1)DE(1)ES(1)US(7)CH(2)