Status:
COMPLETED
CryoValve® SG Aortic Human Heart Valve Combination Study
Lead Sponsor:
CryoLife, Inc.
Conditions:
Aortic Valve Stenosis
Aortic Valve Insufficiency
Eligibility:
All Genders
6-27 years
Brief 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...
Eligibility Criteria
Inclusion
- Patients implanted with a CryoValve SGAV as an aortic valve replacement.
- Patients who were ≤ 21 years of age at the time of implant.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01236469
Start Date
June 1 2010
End Date
February 1 2012
Last Update
August 19 2015
Active Locations (9)
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1
Arizona Pediatric Cardiology Consultants
Phoenix, Arizona, United States, 85006
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Rady Children's Hospital
San Diego, California, United States, 92123
4
The Children's Hsopital
Aurora, Colorado, United States, 80045