Follow Up on Freestyle Valves in Children

Pulmonary Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385112
• Other study ID #: IRB00000124
• Secondary ID: 06-138
• Status: Completed
• Phase: N/A
• First received: October 3, 2006
• Last updated: January 25, 2017
• Start date: November 2006
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Atresia
• Pulmonary Valve Atresia
• Pulmonary Valve Stenosis
• Right Ventricle

Intervention

Procedure:
• Echocardiogram
2D echocardiogram with Doppler flow

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We hypothesize that this Medtronic Freestyle® porcine aortic root valve has good long term hemodynamic performance and longevity.	Retrospective Chart Review	Retrospective Chart Review