Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259207
Status:
COMPLETED
Last Update Posted:
2009-09-30
First Post:
2005-11-28
Brief Title:
Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Pulmonary Valve Replacement Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy
Status:
COMPLETED
Status Verified Date:
2007-03
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:
The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with a large right ventricular outflow tract a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal circulation
Detailed Description:
Pulmonary regurgitation is a common complication late after complete correction of a tetralogy of Fallot It progressively leads to a right ventricular dilatation that has been strongly associated with ventricular arrhythmia sudden death and right ventricular insufficiency Pulmonary valve replacement reduces the rate of complications but the precise timing for this procedure remains unknown Moreover pulmonary valve replacement even before the occurrence of symptoms doesnt allow for a total recovery in all patients Reasons are not known but cardiopulmonary bypass as well as late referral to surgery have been incriminated to explain the persistence of right ventricular dysfunction after surgical valvular Therefore a strategy avoiding cardiopulmonary bypass could potentially preserve the right ventricular function and in the meantime reduce the hospitalisation length and morbid-mortality For the last six years we and others have developed a technique of percutaneous pulmonary valve implantation Encouraging results were reported in the treatment of failing right ventricular to pulmonary artery conduit but presents indications are limited and the innovative technique could not be offered to most of patients requiring pulmonary valve replacement In particular to date conventional surgery is the only approach for patients with large pulmonary trunk over 22 mm in diameter We had the idea of collaborating with the surgeons to try to improve the outcome of valvular in these patients We would like to investigate a hybrid strategy in those patients with large right ventricular outflow tract inaccessible to solely transcatheter technique The studied technique will associate a surgical pulmonary artery banding without cardiopulmonary bypass immediately followed by a transventricular or a transvenous pulmonary valve insertion using a conventional valved stent The purpose of this randomized study is to evaluate benefits and risks of the medico-surgical hybrid strategy and to compare both strategies hybrid approach and conventional surgery with extracorporeal circulation in term of right ventricular function recovery
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 |
|---|---|---|---|
| AOR04068 | None | None | None |