Status:
COMPLETED
Follow Up on Freestyle Valves in Children
Lead Sponsor:
Emory University
Conditions:
Right Ventricle
Pulmonary Valve Stenosis
Eligibility:
All Genders
8-40 years
Brief Summary
The purpose of this study is to determine if the Medtronic Freestyle porcine valve is effective over a long period of time when it is used to replace the valve that normally allows blood to flow from ...
Detailed Description
During the time between June 1998 and June 2006, the Medtronic Freestyle® porcine aortic root (Medtronic, Minneapolis, MN) was used for reconstruction of the right ventricular outflow tract in childre...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients that have received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction that have not had a standard of care echocardiogram performed in the last 12 months.
- Patients that have received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction whose most recent echocardiogram is not useful for evaluating the study points despite the fact that it may have been performed within the last 12 months.
- Informed consent obtained from the legal guardian or patient if \> 18 years of age.
- Exclusion Criteria
- Patients that have not received the Medtronic Freestyle® porcine aortic root for right ventricular outflow tract reconstruction.
- Patients that are eligible to participate based on the previous criteria for whom informed consent is not obtained from the patient or legal guardian.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00385112
Start Date
November 1 2006
End Date
December 1 2016
Last Update
January 26 2017
Active Locations (1)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322