Follow Up on Freestyle Valves in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kirk R. Kanter, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00385112
First received: October 3, 2006
Last updated: June 1, 2014
Last verified: June 2014

October 3, 2006
June 1, 2014
November 2006
December 2015   (final data collection date for primary outcome measure)
We hypothesize that this Medtronic Freestyle® porcine aortic root valve has good long term hemodynamic performance and longevity. [ Time Frame: Retrospective Chart Review ] [ Designated as safety issue: No ]
Retrospective Chart Review
Not Provided
Complete list of historical versions of study NCT00385112 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Follow Up on Freestyle Valves in Children
Follow Up on Freestyle Valves for Right Ventricular Outflow Tract Reconstruction in Children

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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.

  • Right Ventricle
  • Pulmonary Valve Stenosis
  • Pulmonary Valve Atresia
Procedure: Echocardiogram
2D echocardiogram with Doppler flow
Not Provided
Kanter KR, Fyfe DA, Mahle WT, Forbess JM, Kirshbom PM. Results with the freestyle porcine aortic root for right ventricular outflow tract reconstruction in children. Ann Thorac Surg. 2003 Dec;76(6):1889-94; discussion 1894-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
January 2016
December 2015   (final data collection date for primary outcome measure)

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.
Both
8 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00385112
IRB00000124, 06-138
No
Kirk R. Kanter, MD, Emory University
Emory University
Not Provided
Principal Investigator: Kirk R Kanter, MD Emory University
Emory University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP