The purpose of this study is to compare 2 techniques of pulmonary valve replacement in patients with large right ventricular outflow tract : a standard surgical treatment using cardiopulmonary bypass versus a medico-surgical hybrid strategy without extracorporeal circulation

Condition	Intervention	Phase
Significant Pulmonary Valve Regurgitation Right Ventricular Outflow Tract Larger Than 22-Mm in Diameter	Procedure: Pulmonary valve insertion	Phase III

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcomes: Right ventricular function
Secondary Outcomes: Morbidity and mortality; Length of stay
Expected Total Enrollment:  62

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 valvulation. 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 valvulation 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   -   90 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. patient with surgical indication of pulmonary valve replacement
2. for significant pulmonary regurgitation
3. pulmonary trunk diameter > 22mm
4. age >5 years old or weight>20kg
5. acceptation of protocol
6. social regimen security

Exclusion Criteria:

1. no indication of pulmonary valve replacement
2. age < 5 years old or weight < 20kg
3. extra-cardiac disease with a vital prognosis under 6 month
4. heparin and contrast allergy
5. clinical or biological signs of infection
6. pregnancy
7. patients in emergency state
8. people private from freedom
9. patients yet include in an another research protocol during the last months

Please refer to this study by ClinicalTrials.gov identifier  NCT00259207

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, Paris,  75015,  France

Study chairs or principal investigators

Younes BOUDJEMLINE, MD,PhD,  Principal Investigator,  Assistance Publique - Hôpitaux de Paris   

Study ID Numbers:  P040413; AOR04068
Last Updated:  December 8, 2005
Record first received:  November 28, 2005
ClinicalTrials.gov Identifier:  NCT00259207
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2006-01-10