Recruitment

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
Single aortic valve replacement +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency.
First cardiac surgery (no multiple cardiac surgeries)
...
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
Single aortic valve replacement +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency.
First cardiac surgery (no multiple cardiac surgeries)
- No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery
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)
No immunosuppressive regimen any time within the 6 months prior surgery.
Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site

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
Single aortic valve replacement +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency.
First cardiac surgery (no multiple cardiac surgeries)
...
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
Single aortic valve replacement +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency.
First cardiac surgery (no multiple cardiac surgeries)
- No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery
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)
No immunosuppressive regimen any time within the 6 months prior surgery.
Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site

Locations

Barcelona
Nantes
Barcelona
Padova
Winnipeg, Manitoba
...
Barcelona
Nantes
Barcelona
Padova
Winnipeg, Manitoba

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