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.
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.
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
9
sites
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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