Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot

Completed · Not applicable

Conditions studied: Tetralogy of Fallot, Pulmonary Valve Insufficiency, Ventricular Dysfunction, Right

In brief

Repair of tetralogy of Fallot (TOF), the most common form of cyanotic congenital heart disease, usually involves surgery on the outflow of the right ventricle (RV) and the pulmonary valve in order to relieve obstruction to blood flow from the RV to the lungs. This procedure often leads to regurgitation (leakage) of the pulmonary valve, which puts the burden of handling a larger than normal amount of blood flow on the RV. Over the years, that extra burden leads to enlargement of the RV and to a decrease in its function. Treatment often includes surgical insertion or replacement of a new pulmonary valve. Replacement of the damaged pulmonary valve aims to minimize the leakage and help the RV function better. This study is designed to compare two methods of how the operation (called pulmonary valve replacement \[PVR\]) is performed. In the first method, a new valve is inserted and only the area of the old valve is operated on; this is the standard PVR. The second method involves inserting the new valve in the same way as the standard method but, in addition, areas of the right ventricular wall that are scarred and not functioning well are removed (PVR plus right ventricular remodeling). This study will evaluate which method is more effective based on the size and function of the RV measured by cardiac magnetic resonance imaging (CMR) six months following surgery, as compared to its size and function before the operation.

Key facts

Study ID

NCT00112320

Run by

Boston Children's Hospital

People needed

68

Starts

2004-04-01

Expected to finish

2011-08-01

Last updated by the study team

2012-12-04

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing PVR to repair TOF at Children's Hospital Boston
• Pulmonary regurgitation fraction greater than or equal to 25% (measured by CMR) and two or more of the following criteria:
• RV end-diastolic volume index greater than or equal to 150 ml/m2 (Z score greater than 5)
• RV end-systolic volume index greater than or equal to 70 ml/m2
• LV end-diastolic volume index less than or equal to 65 ml/m2
• RV ejection fraction less than 45%
• RVOT aneurysm
• Clinical criteria: exercise intolerance, symptoms and signs of heart failure, and use of cardiac medications

You may not qualify if…

• Presence of either severe RV outflow tract obstruction (defined as peak-to-peak systolic gradient of greater than or equal to 60 mm Hg by cardiac catheterization) or severe RV hypertension at systemic or higher level
• Additional sources of RV volume overload other than PR and tricuspid valve regurgitation
• Contraindications to CMR

Where it is running

• Department of Cardiology, Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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