Follow Up on Freestyle Valves in Children

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 children that underwent surgery at Children's Healthcare of Atlanta. These
children were born with heart problems that made it difficult for blood to flow from the
lower right chamber of the heart to the lungs where it would normally pick up oxygen to be
used by the body. Consequently, these children required surgery to repair the valve and
eliminate this restriction of blood flow to the lungs in order to preserve life. In this
case, the Freestyle valve was used. It is a relatively new valve and it is not known how it
functions and how it impacts overall heart function over a long period of time. We are
requesting permission to recruit volunteers that have received the Freestyle valve for this
purpose in order to determine its long term performance. Specifically, we are seeking
volunteers that are willing to have an echocardiogram performed. It is through the
evaluation of a recent echocardiogram, as it compares to previous echocardiograms performed
on the same patient, that the usefulness of the Freestyle valve will be evaluated for its
durability and its long term impact on heart function.

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.