Pulmonary Valve Replacement in Large Right Ventricular Outflow Tract
Condition: Pulmonary Valve Insufficiency
MeSH terms: Pulmonary Valve Insufficiency
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Pulmonary valve insertion; medical surgery hybride
Intervention type(s): Procedure; Procedure
Intervention description(s): Pulmonary valve insertion; medical surgery hybride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary valve regurgitation; Valve replacement; Hybrid procedure