Overview

This trial is active, not recruiting.

Conditions right ventricle, pulmonary valve stenosis, pulmonary valve atresia
Treatment echocardiogram
Sponsor Emory University
Start date November 2006
End date December 2016
Trial size 100 participants
Trial identifier NCT00385112, 06-138, IRB00000124

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
We hypothesize that this Medtronic Freestyle® porcine aortic root valve has good long term hemodynamic performance and longevity.
time frame: Retrospective Chart Review

Eligibility Criteria

Male or female participants from 8 years up to 40 years old.

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.

Additional Information

Official title Follow Up on Freestyle Valves for Right Ventricular Outflow Tract Reconstruction in Children
Principal investigator Kirk R Kanter, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Emory University.