- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385112
Follow Up on Freestyle Valves in Children
January 25, 2017 updated by: Kirk R. Kanter, MD, Emory University
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
98
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
We hypothesize that this Medtronic Freestyle® porcine aortic root valve has good long term hemodynamic performance and longevity.
Time Frame: Retrospective Chart Review
|
Retrospective Chart Review
|
Retrospective Chart Review
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
October 3, 2006
First Submitted That Met QC Criteria
October 3, 2006
First Posted (Estimate)
October 6, 2006
Study Record Updates
Last Update Posted (Estimate)
January 26, 2017
Last Update Submitted That Met QC Criteria
January 25, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00000124
- 06-138
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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