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

Tetralogy of Fallot Clinical Trial

Official title:

Randomized Trial of Pulmonary Valve Replacement in Tetralogy of Fallot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112320
• Other study ID #: 188
• Secondary ID: P50HL074734P50HL
• Status: Completed
• Phase: N/A
• First received: June 1, 2005
• Last updated: December 3, 2012
• Start date: April 2004
• Est. completion date: August 2011

Study information

• Verified date: December 2012
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 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.

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-term morbidity and mortality, including arrhythmias, sudden death, and right heart failure. Using CMR, there is a high prevalence of regional dysfunction and aneurysms in the RV in patients with repaired TOF. Current standard clinical practice in patients with repaired TOF, severe PR, ventricular dysfunction, and/or clinical deterioration is to insert a bioprosthetic pulmonary valve to reduce the volume load on the RV. Although PVR can be achieved with low mortality, research has shown a persistent or worsening RV dysfunction postoperatively, despite a competent pulmonary valve. In patients with left ventricular (LV) aneurysms, surgical remodeling with aneurysm resection has been shown to improve LV mechanics. In view of the potentially deleterious effects of aneurysmal and akinetic wall segments on RV mechanics, researcher have recently modified their PVR surgical technique in selected patients to include surgical remodeling of the RV with resection of the akinetic wall segments. However, no studies have systematically compared the efficacy of PVR plus surgical RV remodeling to PVR alone.

Research Question:

Is there a difference between two surgical strategies—PVR alone (bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract [RVOT] aneurysm) versus PVR and surgical RV remodeling (bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume)—on RV mechanics and on the incidence of adverse events in patients with repaired TOF and chronic pulmonary regurgitation?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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:

1. RV end-diastolic volume index greater than or equal to 150 ml/m2 (Z score greater than 5)

2. RV end-systolic volume index greater than or equal to 70 ml/m2

3. LV end-diastolic volume index less than or equal to 65 ml/m2

4. RV ejection fraction less than 45%

5. RVOT aneurysm

6. 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Tetralogy of Fallot
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Procedure:
• PVR plus RV remodeling
PVR and surgical RV remodeling, which includes bioprosthetic pulmonary valve insertion and resection of akinetic scarred areas on the anterior RV wall to reduce RV volume
• Standard PVR
PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm

Locations

Country	Name	City	State
United States	Department of Cardiology, Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in ventricular mechanics compared with the preoperative ventricular mechanics		Measured at 6 months	Yes
Secondary	Incidence of one or more postoperative adverse events		Measured at 6 months	Yes

External Links

•   Click here for the Children's Hospital Boston Cardiovascular Program web site