NCT00590889

Artificial Valve Endocarditis Reduction Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 807 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Disease
• Mitral Valve Disease
• Endocarditis

Interventions

Type	Name	Description
DEVICE	Artificial Mechanical Heart Valve	Both arms used market released mechanical heart valves in accordance with approved labeling

Timeline

• Start date: 1998-07-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2008-01-11
• Last updated: 2019-02-27
• Results posted: 2015-12-22

Locations

16 sites across 8 countries: United States, Canada, France, Germany, Italy, Netherlands, Spain, Switzerland