Follow Up on Freestyle Valves in Children

NCT ID: NCT00385112

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2016-12-31

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 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.

Conditions

Right Ventricle; Pulmonary Valve Stenosis; Pulmonary Valve Atresia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Echocardiogram

2D echocardiogram with Doppler flow

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Kirk R. Kanter, MD

Chief, Pediatric Cardiac Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirk R Kanter, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

References

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. doi: 10.1016/s0003-4975(03)01304-3.

Reference Type: RESULT

PMID: 14667606 (View on PubMed)

Other Identifiers

06-138

Identifier Type: -

Identifier Source: secondary_id

IRB00000124

Identifier Type: -

Identifier Source: org_study_id