Follow Up on Freestyle Valves in Children

Completed

Conditions studied: Right Ventricle, Pulmonary Valve Stenosis, Pulmonary Valve Atresia

In brief

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 the right lower pumping chamber of the heart to the lungs.

Key facts

Study ID

NCT00385112

Run by

Emory University

People needed

98

Starts

2006-11-01

Expected to finish

2016-12-01

Last updated by the study team

2017-01-26

Who can join

Age: 8 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Healthcare of Atlanta — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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