NCT01236469

CryoValve® SG Aortic Human Heart Valve Combination Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: CryoLife, Inc. · Industry
• Sex: All
• Age: 6 Years – 27 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Insufficiency

Interventions

Type	Name	Description
PROCEDURE	Echocardiogram	A prospective follow-up Study Echocardiogram will be performed, as applicable, for those subjects who do not have echo data as of January 1, 2009.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-05-01
• Completion: 2012-02-01
• First posted: 2010-11-08
• Last updated: 2015-08-19

Locations

9 sites across 1 country: United States