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Sponsors and Collaborators: |
Assistance Publique - Hôpitaux de Paris Hôpital Necker-Enfants Malades European Georges Pompidou Hospital |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00259207 |
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.
Condition | Intervention | Phase |
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Pulmonary Valve Insufficiency |
Procedure: Pulmonary valve insertion |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-Pump Hybrid Strategy. |
Estimated Enrollment: | 62 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2010 |
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 strategy, and to compare both strategies hybrid approach and conventional surgery with extracorporeal circulation in term of right ventricular function recovery.
Ages Eligible for Study: | 6 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Younes BOUDJEMLINE, MD, PhD | +33(0)-1 44 49 43 57 | younes.boudjemline@nck.aphp.fr |
France | |
NECKER HOSPITAL for Sick Children, 149 R. de SEVRES | Recruiting |
PARIS, France, 75015 | |
Contact: Younes BOUDJEMLINE, MD,PhD +33(0)-1 44 49 43 57 younes.boudjemline@nck.aphp.fr | |
Principal Investigator: Younes BOUDJEMLINE, MD,PhD |
Principal Investigator: | Younes BOUDJEMLINE, MD,PhD | Assistance Publique - Hôpitaux de Paris |
Study ID Numbers: | P040413, AOR04068 |
Study First Received: | November 28, 2005 |
Last Updated: | March 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00259207 |
Health Authority: | France: Ministry of Health |
Pulmonary valve regurgitation Valve replacement Hybrid procedure |
Pulmonary Valve Insufficiency Heart Diseases Heart Valve Diseases |
Cardiovascular Diseases |