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

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

Conditions

• Patients Receiving Animal-derived Bioprosthetic Heart Valves

Interventions

DEVICE

Patients receiving animal-derived bioprosthetic heart valves.

OTHER

Echocardiography (1)

OTHER

Echocardiography (2)

OTHER

Echocardiography (3)

BIOLOGICAL

Blood sample (1)

BIOLOGICAL

Blood sample (2)

BIOLOGICAL

Blood sample (3)

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Jean-christian ROUSSEL, Professor · Nantes University Hospital

• Gino GEROSA, Professor · University of Padova Medical School, Italy

• Rafael MAÑEZ, Professor · University Hospital of Bellvitge, Barcelona, Spain

• Manuel GALIÑANES, Professor · University Hospital Vall d'Hebron, Barcelona, Spain

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-06

Primary Completion

2018-01-10

Completion

2018-01-10

Countries

• Canada
• France
• Italy
• Spain

Study Locations