Follow Up on Freestyle Valves in Children

This study is currently recruiting participants.
Verified November 2013 by Emory University
Sponsor:
Information provided by (Responsible Party):
Kirk R. Kanter, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00385112
First received: October 3, 2006
Last updated: November 19, 2013
Last verified: November 2013
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow Up on Freestyle Valves for Right Ventricular Outflow Tract Reconstruction in Children

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: November 2006
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Echocardiogram
    2D echocardiogram with Doppler flow
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.

  Eligibility

Ages Eligible for Study:   8 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385112

Contacts
Contact: Kirk R Kanter, MD 404-785-6310

Locations
United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Kirk R Kanter, MD Emory University
  More Information

Publications:
Responsible Party: Kirk R. Kanter, MD, Chief, Pediatric Cardiac Surgery, Emory University
ClinicalTrials.gov Identifier: NCT00385112     History of Changes
Other Study ID Numbers: IRB00000124, 06-138
Study First Received: October 3, 2006
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Cardiology
Echocardiograms
Surgery
Valve Disease
Heart Valve Disease

Additional relevant MeSH terms:
Pulmonary Valve Stenosis
Pulmonary Atresia
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 14, 2014