NCT00385112

Follow Up on Freestyle Valves in Children

Follow Up on Freestyle Valves for Right Ventricular Outflow Tract Reconstruction in Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 8 Years – 40 Years
• Healthy volunteers: Accepted

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

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 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.

Conditions

• Right Ventricle
• Pulmonary Valve Stenosis
• Pulmonary Valve Atresia

Interventions

Type	Name	Description
PROCEDURE	Echocardiogram	2D echocardiogram with Doppler flow

Timeline

• Start date: 2006-11-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2006-10-06
• Last updated: 2017-01-26

Locations

1 site across 1 country: United States