Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
Tetralogy of Fallot, Pulmonary Valve Insufficiency, Ventricular Dysfunction, Right
About this trial
This is an interventional treatment trial for Tetralogy of Fallot focused on measuring Pulmonary Valve Regurgitation, Right Ventricular Dysfunction, Heart Diseases
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Department of Cardiology, Children's Hospital Boston
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1
2
Standard PVR
PVR plus RV remodeling