Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112320
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2005-06-01
Brief Title:
Comparison of Two Pulmonary Valve Replacement Methods to Treat Tetralogy of Fallot
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Randomized Trial of Pulmonary Valve Replacement in Tetralogy of Fallot
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50HL074734-01 | NIH | None | httpsreporternihgovquickSearchP50HL074734-01 |
| P50HL074734 | NIH | None | None |