CompletedNot Applicable

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

Canada, France, Italy1,668 participantsStarted 2014-01-06

Plain-language 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

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria To be enrolled, the following criteria have to be fulfilled: \*Phase A: Diagnostic Study Inclusion criteria for SVD-patients: * Patient age: 18 to 85 years old at the time of surgery * Echographic signs of SVD (Mean trans-valvular gradient ≥ 30 mm Hg AND Effective Orifice Area ≤ 1 cm2 worsen over time OR Aortic Insufficiency \> grade 2/4) * Single aortic valve replacement +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency. * First cardiac surgery (no multiple cardiac surgeries) * No immunosuppressive regimen any time within the 6 months prior surgery. * \- No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery * Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to any study related procedure * Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site Non-SVD patients (control-patients): * Patients will be defined as patients operated on with an aortic BHV without echographic signs of SVD and matched for: Age at surgery (±2 years), type of BHV and follow-up time (± 6 months). * Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to any study related procedure * Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational s…

What they're measuring

Echocardiography data to assess the structural valve deterioration

Timeframe: 5 years

Trial details

NCT IDNCT02023970

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01-10