Artificial Valve Endocarditis Reduction Trial

Not Applicable

Terminated

• Conditions: Aortic Valve Disease; Mitral Valve Disease; Endocarditis
• Interventions: Device: Artificial Mechanical Heart Valve

• Registration Number: NCT00590889
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 1998-07
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-06-22
• Results First Submitted QC: 2015-11-18
• Results First Posted: 2015-12-22
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 807

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
St. Jude Medical (SJM) Silzone	Artificial Mechanical Heart Valve	St. Jude Medical (SJM) Masters Series Mechanical Heart Valve with Silzone Coating
St. Jude Medical (SJM) Conventional	Artificial Mechanical Heart Valve	St. Jude Medical (SJM) Standard Masters Series Mechanical Heart Valve with Conventional Cuff

Primary Outcome Measures

Name	Time	Method
Incidence of Prosthetic Valve Endocarditis Comparing Conventional Valves to Silzone™ Coated Valves.	1 year	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.

Trial Locations

Locations (16)

Hopital Regional-Service de Cardiologie; 🇨🇭 Sion, Switzerland

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Florida Heart Group; 🇺🇸 Orlando, Florida, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Brigham and Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Texas Heart Institute; 🇺🇸 Houston, Texas, United States

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Sisters of Providence Health System; 🇺🇸 Portland, Oregon, United States

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States

Hôpital G. Et R. Laënnec; 🇫🇷 Nantes, France

Fond Ne Centro S. Raffaele; 🇮🇹 Milan, Italy

Deutches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Inselspital; 🇨🇭 Bern, Switzerland

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands