search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PVR plus RV remodeling
Standard PVR
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Standard PVR

PVR plus RV remodeling

Outcomes

Primary Outcome Measures

Changes in ventricular mechanics compared with the preoperative ventricular mechanics

Secondary Outcome Measures

Incidence of one or more postoperative adverse events

Full Information

First Posted
June 1, 2005
Last Updated
December 3, 2012
Sponsor
Boston Children's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00112320
Brief Title
Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
Official Title
Randomized Trial of Pulmonary Valve Replacement in Tetralogy of Fallot
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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-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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetralogy of Fallot, Pulmonary Valve Insufficiency, Ventricular Dysfunction, Right
Keywords
Pulmonary Valve Regurgitation, Right Ventricular Dysfunction, Heart Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard PVR
Arm Title
2
Arm Type
Experimental
Arm Description
PVR plus RV remodeling
Intervention Type
Procedure
Intervention Name(s)
PVR plus RV remodeling
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Standard PVR
Intervention Description
PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm
Primary Outcome Measure Information:
Title
Changes in ventricular mechanics compared with the preoperative ventricular mechanics
Time Frame
Measured at 6 months
Secondary Outcome Measure Information:
Title
Incidence of one or more postoperative adverse events
Time Frame
Measured at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tal Geva, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20837914
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs