TRANSLINK: Defining the Role of Xeno-directed and Immune Events (SVD) in Patients Receiving Animal-derived Bioprosthetic Heart Valves
Condition: Patients Receiving Animal-derived Bioprosthetic Heart Valves
Study type: Interventional

Summary: 
      Cardiac valve disorders are widely spread in the general population and represents the third
      most frequent cardiovascular illness after coronary disease and arterial hypertension. In
      this context, aortic valve stenosis (the central pathology in this project) is the most
      common form of valve disease. Cardiac valve replacement is in the vast majority of cases the
      first line therapy for degenerative heart-valve diseases. These are represented by mechanical
      and bioprosthetic valve (BHV). In the vast majority of cases, BHV are derived from animals
      and from a biological standpoint are classified as xenografts. BHV are severely penalised by
      a premature structural damage, with ultimate valve failure occurring around 10 years after
      surgery in 5 to 30% of cases, depending on the type of BHV used. Several factors [including
      dyslipidaemia, gender, valve position] may contribute to the ultimate failure of the BHV and
      there has been increasing evidence recently of a substantial immune reaction elicited by the
      implanted BHV. This immune response is still poorly understood. It may lead to adverse immune
      reactions and this will be thoroughly investigated by the TRANSLINK team. In this light, the
      TRANSLINK project aims to provide the necessary data to demonstrate beyond any reasonable
      doubt the central role of the anti-BHV immune response in the premature failure of BHV and to
      provide efficient strategies to enable safe implantation of BHV valves in currently
      unsuitable candidates
    


Intervention name(s): Patients receiving animal-derived bioprosthetic heart valves.; Echocardiography (1); Echocardiography (2); Echocardiography (3); Blood sample (1); Blood sample (2); Blood sample (3)
Intervention type(s): Device; Other; Other; Other; Biological; Biological; Biological
Other intervention name(s): Echocardiography at the baseline (inclusion visit); Echocardiography will be performed at visits before surgery, 6, 24 and 42 months at inclusion site.; At inclusion visit and:; - If normal echocardiographic parameters (without SVD signs): echocardiography at 42 months.; - If subnormal echocardiographic parameters (SVD signs): echocardiographic follow-up will be performed on site at 1 year and 42 months.; Blood sample will be collected at the time of SVD diagnosis in SVD patients and non -SVD control patients.; Blood samples will be harvested the day before the surgery and then at 1, 6, 12, 24 and 42 months, representing 6 samples per patient.; At inclusion visit and:; - If normal echocardiographic parameters (without SVD signs): blood samples at 2 year and 42 months; - If subnormal echocardiographic parameters (SVD signs): blood samples at 1 year and 42 months.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Bioprosthetic heart valves, immune response, structural valve deterioration, valvular disease