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Use of the Medtronic Contegra Pulmonary Valved Conduit Device: Humanitarian Use Device (HUD)
Study ID: STU 022011-029
Summary
The Contegra[RegisteredTM] pulmonary valved conduit is used to allow surgical correction or reconstruction of the right ventricular outflow tract in congenital heart malformations. The Contegra[RegisteredTM] pulmonary valved conduit is placed either inside the heart in the natural position of the pulmonary valve or outside of the heart to provide an alternative path for blood flow. How the valve is implanted depends on each patient's condition. The current treatments for replacement of pediatric heart valves include mechanical heart valves and tissue valves. These current treatment modalities have risks. These risks include infection, hemolysis, prosthesis nonstructural dysfunction, rejection, calcification, prosthesis dilation, and stenosis. These risks are the same for the Contegra[RegisteredTM] pulmonary valved conduit. it is not known if the Contegra[RegisteredTM] pulmonary valved conduit is a better treatment for replacement of heart valves but it gives another treatment option for replacement of pediatric heart valves. The Contegra[RegisteredTM] pulmonary valved conduit has not shown to have increased risks than the current treatments. although it has been shown to provide a better variety of sizes for the pediatric patient that are not available with the current valve treatments. This makes the Contegra[RegisteredTM] pulmonary valved conduit fit better and, because of the ease of placement, decrease the surgery time and makes the surgery less complicated. The decision to use this device will be made in conjunction with the subject's pediatric cardiologist.
Participant Eligibility
1) Must be less than 18 years of age 2) Have one of the following congenital heart malformations a) Pulmonary Stenosis b) Tetralogy of Fallot c) Truncus Arteriosus d) Transposition with Ventricular Septal Defect e) Pulmonary Atresia 3) The conduit is indicated for the replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- TIMOTHY JOHN PIROLLI
UNIVERSITY OF TEXAS SOUTHWESTERN
The purpose of this device is to provide another choice for valve replacement or homograph. The current medical treatment to replace heart valves includes mechanical heart valves and tissue heart valves. Mechanical heart valves last longer than both bioprosthetic and human tissue valves, making them more suitable for younger patients. nevertheless, despite the improved performance of the modern mechanical valves, they all have shown significant leakage and formation of blood clots and hemolysis and platelet lysis. Tissue valves are also a current treatment for valve replacement. Tissue valves are made from animal tissue (bioprosthesis) or made from human tissue (homografts and autografts). Tissue valves are much less harmful to the blood constituents. Tissue valves maintain low rates of thromboembolism and their recipients are generally not anticoagulated. However, progressive tissue deterioration and subsequent structural dysfunction have been shown. This is most likely due to both calcification and non-calcific mechanisms that frequently occur on tissue valves. Valve infection and non-structural dysfunction affect both tissue and mechanical valves almost equally. These current medical options have provided limited sizes for the smaller patient creating fewer options for treatment. The Contegra[RegisteredTM] pulmonary valved conduit is made of a natural product (bovine jugular vein) and had a variety of sizes available for children. With a better fit the Contegra[RegisteredTM] pulmonary valved conduit has been shown to stand up better to the pressures of circulation and long term use. The Contegra[RegisteredTM] pulmonary valved conduit does have the same risk factors as the current treatment modalities; these include infection, deterioration, leaking, clot formation and reoperation due to dysfunction or patient growth. But no increased risks or difficulties have been reported with the Contegra[RegisteredTM] pulmonary valved conduit. Currently, the sponsor is preparing for FDa pre-market approval submission, and this project provides another option for treatment of valve replacement.