Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract

Study Overview
=================
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.

Official Title
-----------------
Pulmonary Valve Replacement : Study of Comparison Between a Standard Surgical Approach With Extracorporeal Circulation and an Off-pump Hybrid Strategy.

Conditions
-----------------
Pulmonary Valve Insufficiency

Intervention / Treatment
-----------------
* Procedure: Pulmonary valve insertion
* Procedure: medical surgery hybride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with surgical indication of pulmonary valve replacement for significant pulmonary regurgitation Pulmonary trunk diameter > 22mm Age > 5 years old or weight > 20kg Acceptance of protocol Social regimen security Exclusion Criteria: No indication of pulmonary valve replacement Age < 5 years old or weight < 20kg Extra-cardiac disease with a vital prognosis under 6 months Heparin and contrast allergy Clinical or biological signs of infection Pregnancy Patients in emergency state Patients included in an another research protocol during the last months

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: classic surgery<br>classic surgery | Procedure: Pulmonary valve insertion<br>* Pulmonary valve insertion<br>|
| Experimental: medical surgery hybride<br>medical surgery hybride | Procedure: medical surgery hybride<br>* medical surgery hybride<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Right ventricular function |  | during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and mortality |  | during the study | 
| Length of stay |  | during the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary valve regurgitation, Valve replacement, Hybrid procedure