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Patients Receiving Animal-derived Bioprosthetic Heart ValvesTRANSLINKNCT02023970

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

A study testing Patients receiving animal-derived bioprosthetic heart valves., Echocardiography (1) and Echocardiography (2) in people with Patients Receiving Animal-derived Bioprosthetic Heart Valves, run by Nantes University Hospital at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Patients receiving animal-derived bioprosthetic heart valves., Echocardiography (1) and Echocardiography (2)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,668 participants
Where
5 sitesin 4 countries
Study dates
6 Jan 2014to 10 Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be enrolled, the following criteria have to be fulfilled:
  • Phase A: Diagnostic Study
  • 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)
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  • 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 site
  • To increase the statistical power (which cannot be calculated according to the novelty of the project), two controls will be matches with each SVD-Case.
  • Phase B: Prospective Study
  • B1: Cohort of prevalent patients
  • Patient age: 18 - 85 years old at the time of surgery
  • Patient scheduled for single aortic valve replacement with a BHV (surgical or percutaneous valve) +/- 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 and no immunosuppressive regimen after surgery.
  • No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery
  • Patient is affiliated to the Social Security or equivalent system
  • 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 Eight of the most frequently implanted BHV worldwide will be assessed: 1 surgical porcine valve: Mosaic (Medtronic); 4 surgical bovine pericardium valves: Perimount-Carpentier (Edwards), Magna ease (Edwards), Trifecta (St. Jude Medical) and the Mitroflow PRT valve (Sorin); 1 surgical equine valve: 3F-valve or Enable (Medtronic) and 2 percutaneous pericardium valves (TAVI): Corevalve (porcine pericardium - Medtronic) and Sapien valve (bovine pericardium - Edwards).
  • Fifty patients per type of BHV will be included. When 50 patients were included in one of the eight groups, we will stop the inclusions in this group.
  • Additionally, a control group of heart operated patients without biological valve will be included in the study (patients operated on with a mechanical valve (n=50) or for CABG without BHV (n=50).
  • Control group (CABG or aortic mechanical valve)
  • Patient age: >65 years old for CABG and 18-85 years old for mechanical valve replacement
  • Patient operated on coronary artery bypass (for CABG group)
  • Patient with valve aortic replacement following aortic valve stenosis (for mechanical valve group)
  • No immunosuppressive regimen any time within the 6 months prior surgery and no immunosuppressive regimen after surgery.
  • No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery.
  • B2: Cohort of incident patients
  • Patient age: 18 to 85 years old (at the time of surgery) who underwent a single isolated aortic valve replacement with a BHV +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency. more than 5 years ago.
  • First cardiac surgery (no multiple cardiac surgeries)
  • No immunosuppressive regimen any time within the 6 months before inclusion and no immunosuppressive regimen after inclusion.
  • Patient is affiliated to the Social Security or equivalent system
  • 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
  • As control, patients who underwent isolated CABG (n=50) or aortic mechanical valve replacement more than 5 years ago (n=50) will be enrolled.
  • Control group (CABG or aortic mechanical valve)
  • Patient age (at the time of surgery): > 65 years old for CABG and 18-85 years old for mechanical valve replacement
  • Patient operated on coronary artery bypass (for CABG group) more than 5 years ago
  • Patient with valve aortic replacement following aortic valve stenosis (for mechanical valve group) more than 5 years ago
  • No immunosuppressive regimen any time within the 6 months prior inclusion and no immunosuppressive regimen after inclusion.
  • No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery

Who cannot join

  • Any of the following is regarded as criteria for exclusion from the study:
  • Female of child bearing potential
  • Severe renal insufficiency: GFR <=30 ml/min/
  • Severe dyslipidemia: total cholesterol >350 mg/dl, triglycerides >750 mg/dl
  • Ongoing infection (patient may be evaluated for enrolment after resolution)
  • HIV infection
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  • Active autoimmune disease
  • Multiple cardiac surgeries
  • Patient with immunosuppression regimen
  • Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that the Investigator feels would restrict or limit the patient's successful participation for the inclusion or duration of the study
  • Presence of any severe medical condition such that the patient is not expected to survive for the planned study follow-up period.
  • Patient is not able to give informed consent
  • Patient under trusteeship or under guardianship
  • No affiliation to a social security or equivalent system
  • Patient is currently participating in an investigational drug or device study that clinically interferes with the current study endpoints

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

Spain2 sites

  • University Hospital of Bellvitge, Barcelona, Spain

    Barcelona

  • University Hospital Vall d'Hebron, Barcelona, Spain

    Barcelona

Other trials in Spain

Canada1 site

  • University of Manitoba

    Winnipeg, Manitoba

Other trials in Canada

France1 site

  • Nantes University Hospital

    Nantes

Other trials in France

Italy1 site

  • University of Padova Medical School, Italy

    Padova

Other trials in Italy

About this study

Official title: TRANSLINK: A Prospective, Multi-center, Multi-national, Non Randomized, Open, Study to Defining the Role of Xeno-directed and Immune Events (SVD) in Patients Receiving Animal-derived Bioprosthetic Heart Valves.

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

Being tested
Patients receiving animal-derived bioprosthetic heart valves., Echocardiography (1), Echocardiography (2), Echocardiography (3), Blood sample (1)
Keywords
Bioprosthetic heart valves, immune response, structural valve deterioration, valvular disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients receiving animal-derived bioprosthetic heart valves.Device

  • Echocardiography (1)Other

    Also called Echocardiography at the baseline (inclusion visit)

  • Echocardiography (2)Other

    Also called Echocardiography will be performed at visits before surgery, 6, 24 and 42 months at inclusion site.

  • Echocardiography (3)Other

    Also called 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 (1)Biological

    Also called Blood sample will be collected at the time of SVD diagnosis in SVD patients and non -SVD control patients.

  • Blood sample (2)Biological

    Also called 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.

  • Blood sample (3)Biological

    Also called 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.

Study groups in NCT02023970
Study groupRoleWhat they receive
Phase A: Diagnostic StudyOtherObjective: to assess the differential immune response in patients with or without SVD (given the low rate of SVD) a matched cases-controls study allows a powerful statistical analysis avoiding main confounding factors for a first discovery of a SVD-specific immune response. Results will be validated in prospective Phase B.
Receives: Device: Patients receiving animal-derived bioprosthetic heart valves.; Other: Echocardiography (1); Biological: Blood sample (1)
Phase B1 (Prospective Study): Cohort of prevalent patientsOtherThis cohort is specifically designed to study the kinetics of the immune response before and after implantation of an aortic BHV. Eight of the most frequently implanted BHV worldwide will be assessed:
Receives: Device: Patients receiving animal-derived bioprosthetic heart valves.; Other: Echocardiography (2); Biological: Blood sample (2)
Phase B2 (Prospective Study): Cohort of incident patientsOtherDue to the low incidence of SVD during the first 4 post-operative years, a second cohort will be constituted by patients undergone biological aortic valve replacement at least 5 years before. The objective of this second cohort is to cover a period of time where risk of SVD occurrence is potentially high.
Receives: Device: Patients receiving animal-derived bioprosthetic heart valves.; Other: Echocardiography (3); Biological: Blood sample (3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Echocardiography data to assess the structural valve deterioration

    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.

    Measured: 5 years

Secondary outcomes (3)

  1. Process of valve degeneration according to the type of BHV

    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.

    Measured: 5 years

  2. Large international and prospective patient's cohort and clinical database with a biocollection

    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.

    Measured: 5 years

  3. Clinic-biological correlations

    To analyse clinic-biological correlations prospectively following BHV.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2013 (estimated)
  2. Study start6 Jan 2014
  3. Primary completion10 Jan 2018
  4. Study completion10 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,668 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02023970
Sponsor's protocol ID
RC13_0241
Acronym
TRANSLINK
Status last verified
Oct 2020
First submitted
5 Dec 2013
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No

Publications

  • Senage T, Paul A, Le Tourneau T, Fellah-Hebia I, Vadori M, Bashir S, Galinanes M, Bottio T, Gerosa G, Evangelista A, Badano LP, Nassi A, Costa C, Cesare G, Manji RA, Cueff de Monchy C, Piriou N, Capoulade R, Serfaty JM, Guimbretiere G, Dantan E, Ruiz-Majoral A, Coste du Fou G, Leviatan Ben-Arye S, Govani L, Yehuda S, Bachar Abramovitch S, Amon R, Reuven EM, Atiya-Nasagi Y, Yu H, Iop L, Casos K, Kuguel SG, Blasco-Lucas A, Permanyer E, Sbraga F, Llatjos R, Moreno-Gonzalez G, Sanchez-Martinez M, Breimer ME, Holgersson J, Teneberg S, Pascual-Gilabert M, Nonell-Canals A, Takeuchi Y, Chen X, Manez R, Roussel JC, Soulillou JP, Cozzi E, Padler-Karavani V. The role of antibody responses against glycans in bioprosthetic heart valve calcification and deterioration. Nat Med. 2022 Feb;28(2):283-294. doi: 10.1038/s41591-022-01682-w. Epub 2022 Feb 17.

    PubMed 35177855

Questions about this trial

What is this clinical trial studying?

A study testing Patients receiving animal-derived bioprosthetic heart valves., Echocardiography (1) and Echocardiography (2) in people with Patients Receiving Animal-derived Bioprosthetic Heart Valves, run by Nantes University Hospital at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 47 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain, Canada, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Echocardiography data to assess the structural valve deterioration (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02023970, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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