TRANSLINK: Defining the Role of Xeno-directed and Immune Events (SVD) in Patients Receiving Animal-derived Bioprosthetic Heart Valves
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 2925
Inclusion Criteria
- 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
- First cardiac surgery (no multiple cardiac surgeries)
- 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)
- ...
- 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
- First cardiac surgery (no multiple cardiac surgeries)
- 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)
- No immunosuppressive regimen any time within the 6 months prior surgery.
- Patient age: 18 to 85 years old at the time of surgery
- Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
- - No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery
- Single aortic valve replacement +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency.
Summary
- Conditions
- Patients Receiving Animal-derived Bioprosthetic Heart Valves
- Type
- Interventional
- Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Inclusion Criteria
- 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
- First cardiac surgery (no multiple cardiac surgeries)
- 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)
- ...
- 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
- First cardiac surgery (no multiple cardiac surgeries)
- 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)
- No immunosuppressive regimen any time within the 6 months prior surgery.
- Patient age: 18 to 85 years old at the time of surgery
- Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
- - No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery
- Single aortic valve replacement +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency.
Locations
- Winnipeg, Manitoba
- Padova
- Nantes
- Barcelona
- Barcelona
- ...
- Winnipeg, Manitoba
- Padova
- Nantes
- Barcelona
- Barcelona
Tracking Information
- NCT #
- NCT02023970
- Collaborators
- Not Provided
- Investigators
- Study Chair: Jean-christian ROUSSEL, Professor Nantes University Hospital Principal Investigator: Gino GEROSA, Professor University of Padova Medical School, Italy Principal Investigator: Rafael MAÑEZ, Professor University Hospital of Bellvitge, Barcelona, Spain Principal Investigator: Manuel GALIÑANES, Professor University Hospital Vall d'Hebron, Barcelona, Spain
- Study Chair: Jean-christian ROUSSEL, Professor Nantes University Hospital Gino GEROSA, Professor University of Padova Medical School, Italy Principal Investigator: Rafael MAÑEZ, Professor University Hospital of Bellvitge, Barcelona, Spain Principal Investigator: Manuel GALIÑANES, Professor University Hospital Vall d'Hebron, Barcelona, Spain
Get Well Soon