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

Launched by NANTES UNIVERSITY HOSPITAL · Dec 23, 2013

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Eligibility criteria

• • Inclusion criteria
• To be enrolled, the following criteria have to be fulfilled:
• • \*Phase A: Diagnostic Study
• Inclusion criteria for SVD-patients:
• • 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)
• • 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
• • Exclusion criteria
• 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
• • 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