Status:
COMPLETED
Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Tetralogy of Fallot
Pulmonary Valve Insufficiency
Eligibility:
All Genders
10+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Background: Surgical repair of TOF often results in chronic pulmonary regurgitation (PR) with associated RV dilatation and dysfunction. Mounting evidence indicates that PR leads to significant long-t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00112320
Start Date
April 1 2004
End Date
August 1 2011
Last Update
December 4 2012
Active Locations (1)
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1
Department of Cardiology, Children's Hospital Boston
Boston, Massachusetts, United States, 02115