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CryoValve® SG Aortic Human Heart Valve Combination Study — SGAV  

Aortic Valve Stenosis Clinical Trial

Official title:
CryoValve® SG Aortic Human Heart Valve Combination Retrospective/Prospective, Multi-Center, Cohort Study

Clinical Trial Summary

The purpose of this study is to assess the probable benefit of CryoValve SG Aortic Human Heart Valve used in pediatric patients as an aortic valve replacement.

Clinical Trial Description

The CryoValve SG aortic human heart valve is recovered from deceased human donors, treated with the SynerGraft® (SG) process,which is designed to reduce the donor cells present on the graft. The valve is then cryopreserved for storage until use. Removing cells from the heart valve has been shown to reduce a component of the immune response after implant compared to a standard allograft valve. However, it is not known how this affects the long-term durability of the valve. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01236469
Study type Observational
Source CryoLife, Inc.
Contact
Status Completed
Phase N/A
Start date June 2010
Completion date February 2012
View Details
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