CryoValve® SG Aortic Human Heart Valve Combination Study

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	6 - 27
Updated:	4/21/2016
Start Date:	June 2010
End Date:	February 2012

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

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.

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.

Inclusion Criteria:

- Patients implanted with a CryoValve SGAV as an aortic valve replacement.

- Patients who were ≤ 21 years of age at the time of implant.

Exclusion Criteria:

- Patients in whom the CryoValve SGAV was used as a patch or a non-valved conduit.

- Patients implanted with a CryoValve SGAV as a pulmonary valve replacement.

- Patients that were ≥ 22 years of age at the time of implant.

We found this trial at

sites

Indiana University

425 University Blvd.
Indianapolis, Indiana 46202

(317) 274-4591