- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00112320
Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
Randomized Trial of Pulmonary Valve Replacement in Tetralogy of Fallot
Study Overview
Status
Intervention / Treatment
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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Department of Cardiology, Children's Hospital Boston
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Standard PVR
|
PVR alone, which includes bioprosthetic pulmonary valve insertion and, when present, resection of right ventricular outflow tract (RVOT) aneurysm
|
Experimental: 2
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in ventricular mechanics compared with the preoperative ventricular mechanics
Time Frame: Measured at 6 months
|
Measured at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of one or more postoperative adverse events
Time Frame: Measured at 6 months
|
Measured at 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tal Geva, MD, Boston Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 188
- P50HL074734 (U.S. NIH Grant/Contract)
- P50HL074734-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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