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

Not Applicable

Completed

• Conditions: Patients Receiving Animal-derived Bioprosthetic Heart Valves

• Registration Number: NCT02023970
• Lead Sponsor: Nantes University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Study Start: 2014-01-06
• Primary Completion: 2018-01-10
• Study Completion: 2018-01-10
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1668

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Echocardiography data to assess the structural valve deterioration	5 years	The primary endpoint to be analyzed in the study is assessment by echocardiography of structural valve deterioration after implantation of pig valve or bovine pericardium valve or equine pericardium valve.; TRANSLINK project aims primarily at establishing the possible role of recipient immune response against biological prosthetic heart valves as a major cause to mid-long-term structural valve deterioration and clinical dysfunction.

Secondary Outcome Measures

Name	Time	Method
Process of valve degeneration according to the type of BHV	5 years	To study the process of valve degeneration according to the type of BHV (porcine, bovine or equine BHV or type of industrial process) and BHV clinical outcome.
Large international and prospective patient's cohort and clinical database with a biocollection	5 years	To implement a large international and prospective patient's cohort and clinical database with a biocollection (biobank) of patients receiving an aortic BHV to identify immune biomarkers following aortic valve replacement.
Clinic-biological correlations	5 years	To analyse clinic-biological correlations prospectively following BHV.

Trial Locations

Locations (5)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Nantes University Hospital; 🇫🇷 Nantes, France

University of Padova Medical School, Italy; 🇮🇹 Padova, Italy

University Hospital of Bellvitge, Barcelona, Spain; 🇪🇸 Barcelona, Spain

University Hospital Vall d'Hebron, Barcelona, Spain; 🇪🇸 Barcelona, Spain