Clinical trial NCT00259207: Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
Official title: Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Valve Insufficiency
Keywords: Pulmonary valve regurgitation
Valve replacement
Hybrid procedure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Hôpital Necker-Enfants Malades
name: European Georges Pompidou Hospital
First posted: 2005-11-29
Enrollment: 8
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

Eligibility criteria: Inclusion Criteria:

1. Patient with surgical indication of pulmonary valve replacement for significant pulmonary regurgitation
2. Pulmonary trunk diameter \> 22mm
3. Age \> 5 years old or weight \> 20kg
4. Acceptance of protocol
5. 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 months
4. Heparin and contrast allergy
5. Clinical or biological signs of infection
6. Pregnancy
7. Patients in emergency state
8. Patients included in an another research protocol during the last months

Primary outcomes:
measure: Right ventricular function
timeFrame: during the study
Secondary outcomes:
measure: Morbidity and mortality
timeFrame: during the study
measure: Length of stay
timeFrame: during the study
Other outcomes:
Locations:
city: Paris
country: France
facility: NECKER HOSPITAL for Sick Children, 149 R. de SEVRES
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Younes BOUDJEMLINE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boudjemline Y, Schievano S, Bonnet C, Coats L, Agnoletti G, Khambadkone S, Bonnet D, Deanfield J, Sidi D, Bonhoeffer P. Off-pump replacement of the pulmonary valve in large right ventricular outflow tracts: a hybrid approach. J Thorac Cardiovasc Surg. 2005 Apr;129(4):831-7. doi: 10.1016/j.jtcvs.2004.10.027.