Clinical Trial: Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.
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 Summary: 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, doesn't 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
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome: Right ventricular function [ Time Frame: during the study ]
Original Primary Outcome: Right ventricular function
Current Secondary Outcome:
- Morbidity and mortality [ Time Frame: during the study ]
- Length of stay [ Time Frame: during the study ]
Original Secondary Outcome:
- Morbidity and mortality
- Length of stay
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: November 28, 2005
Date Started: December 2005
Date Completion:
Last Updated: September 29, 2009
Last Verified: March 2007
