Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385112
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2006-10-03
Brief Title:
Follow Up on Freestyle Valves in Children
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Follow Up on Freestyle Valves for Right Ventricular Outflow Tract Reconstruction in Children
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Childrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-138 | None | None | None |