Pleiades Safety and Feasibility Study

The "Pleiades" study is a non randomised, prospective, single center clinical trial that aims to evaluate the safety and the procedural feasibility of an innovative flow assist device (Pleioflow-RF) in adult patients undergoing elective cardiac surgery.

Inclusion Criteria:Age ≥ 18 and ≤ 85, men and womenElective coronary artery bypass grafting surgery and/or heart valve surgery with planned CPB.Written informed consent providedHaemoglobulin (Hb) ≥ 11 g/dl in women and ≥ 12 g/dl for menEjection fraction ≥ 30%Score≥ 3 according to the Cleveland Clinic Foundation risk factor scale for AKI and / or Chronic Kidney Disease (CKD) with preoperative glomerular filtration rate, estimated glomerular filtration rate, eGFR ≤50 ml / min / 1.7, 3 m2) as estimated by the equation of four Modified Diet and Renal Disease variables (MDRD type)Exclusion Criteria:emergency surgerysevere sepsis or rhabdomyolysissevere preoperative renal insufficiency requiring renal replacement therapy (RRT) or even once RRTreceiving within the last 10 days nephrotoxic medications, such as radiocontrast material (> 100 ml), amphotericin B, aminoglycosides, NSAID, or trimethoprim-sulfamethoxazole with at least moderate renal impairment (eGFR ≤45)Any severe coagulopathyParticipation in another trialAny surgical or medical condition which according to investigator's opinion could create problem in the assessment of safety and /or efficacy of the deviceSevere comorbidity with life expectancy < 6 monthsHistory of poor compliance with previous treatment and incapability of giving informed consentPregnant or breastfeeding women. Pregnancy, confirmed by a positive laboratory test for Human Chorionic Gonadotropin, is considered from the time after conception until the end of the pregnancy.Peripheral artery disease making insertion of IABP unfeasiblePreoperative intra-aortic balloon pump (IABP)Preoperative other device in the same anatomical area (which could possibly create dysfunction of any of the other two devices)