NCT02023970: TRANSLINK

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

Completed NA Last updated 2 November 2020

What this trial tests

NA trial testing Patients receiving animal-derived bioprosthetic heart valves. in Patients Receiving Animal-derived Bioprosthetic Heart Valves in 1,668 participants. Completed in 10 January 2018.

Timeline

6 January 2014

Primary endpoint
10 January 2018

10 January 2018

Quick facts

Lead sponsor	Nantes University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	1,668
Start date	6 January 2014
Primary completion	10 January 2018
Estimated completion	10 January 2018
Sites	5 locations across France, Canada, Spain, Italy

Drugs / interventions tested

• Patients receiving animal-derived bioprosthetic heart valves.
• Echocardiography (1)
• Echocardiography (2)
• Echocardiography (3)
• Blood sample (1) — full drug profile →
• Blood sample (2) — full drug profile →
• Blood sample (3) — full drug profile →

Conditions studied

• Patients Receiving Animal-derived Bioprosthetic Heart Valves — all drugs for Patients Receiving Animal-derived Bioprosthetic Heart Valves →

Sponsor

Nantes University Hospital

Who can join

Adults 18 to 85, any sex, with Patients Receiving Animal-derived Bioprosthetic Heart Valves. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of antibody responses against glycans in bioprosthetic heart valve calcification and deterioration.
   Senage T, Paul A, Le Tourneau T, Fellah-Hebia I, et al · · 2022 · cited 67× · PMID 35177855 · DOI 10.1038/s41591-022-01682-w
2. Oxidative Stress in Structural Valve Deterioration: A Longitudinal Clinical Study.
   Galiñanes M, Casós K, Blasco-Lucas A, Permanyer E, et al · · 2022 · cited 8× · PMID 36358956 · DOI 10.3390/biom12111606
3. Humoral immune responses to hyaluronan oligosaccharides in patients undergoing prosthetic valve surgery.
   Bello-Gil D, Olivera-Ardid S, Blasco-Lucas A, Sbraga F, et al · · 2026 · PMID 41789079 · DOI 10.3389/fimmu.2026.1762676