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| Sponsored by: |
Emory University |
|---|---|
| Information provided by: | Emory University |
| ClinicalTrials.gov Identifier: | NCT00385112 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Right Ventricle Pulmonary Valve Stenosis Pulmonary Valve Atresia |
Procedure: Echocardiogram |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Follow Up on Freestyle Valves for Right Ventricular Outflow Tract Reconstruction in Children |
| Estimated Enrollment: | 45 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 8 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| Contact: Kirk R Kanter, MD | 404-785-6310 |
| United States, Georgia | |
| Children's Healthcare of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Principal Investigator: | Kirk R Kanter, MD | Emory University |
More Information
| Responsible Party: | Emory University Institutional Review Board ( chairman ) |
| Study ID Numbers: | IRB00000124, 06-138 |
| Study First Received: | October 3, 2006 |
| Last Updated: | September 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00385112 |
| Health Authority: | United States: Institutional Review Board |
|
Cardiology Echocardiograms Surgery Valve Disease Heart Valve Disease |
|
Pulmonary Valve Stenosis Pulmonary Atresia Pulmonary valve stenosis Heart Diseases Cardiovascular Abnormalities |
Vascular Malformations Constriction, Pathologic Congenital Abnormalities Heart Valve Diseases |
|
Cardiovascular Diseases Ventricular Outflow Obstruction |
