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

NCT00112320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2012-12-04

No results posted yet for this study

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

Interventions

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

PROCEDURE

Standard PVR

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

Sponsors & Collaborators

Principal Investigators

  • Tal Geva, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00112320 on ClinicalTrials.gov