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

NCT00112320 | Completed DMC

• 3 other identifiers: 188P50HL074734P50HL074734-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Tetralogy of Fallot; Pulmonary Valve Insufficiency; Ventricular Dysfunction, Right

Keywords

Pulmonary Valve Regurgitation; Right Ventricular Dysfunction; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Changes in ventricular mechanics compared with the preoperative ventricular mechanics

  Measured at 6 months

Secondary Outcomes (1)

• Incidence of one or more postoperative adverse events

  Measured at 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Standard PVR

Procedure: Standard PVR

2

EXPERIMENTAL

PVR plus RV remodeling

Procedure: PVR plus RV remodeling

Interventions

PVR plus RV remodeling PROCEDURE

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

2

Standard PVR PROCEDURE

PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm

1

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Department of Cardiology, Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Geva T, Gauvreau K, Powell AJ, Cecchin F, Rhodes J, Geva J, del Nido P. Randomized trial of pulmonary valve replacement with and without right ventricular remodeling surgery. Circulation. 2010 Sep 14;122(11 Suppl):S201-8. doi: 10.1161/CIRCULATIONAHA.110.951178.

  PMID: 20837914 DERIVED

MeSH Terms

Conditions

Tetralogy of Fallot; Pulmonary Valve Insufficiency; Ventricular Dysfunction, Right; Heart Diseases

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Valve Diseases; Ventricular Dysfunction

Study Officials

• Tal Geva, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: June 1, 2005
• First Posted: June 2, 2005
• Study Start: April 1, 2004
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

US (1)