Evaluating a new flow assist device for heart surgery

Non Randomised, Prospective, Single Center Clinical Study to Evaluate the Safety and Procedural Feasibility of an Innovative Flow Assist Device, Pleioflow-RF.

This study is testing a new device that helps improve blood flow during heart surgery to see if it can protect patients' kidneys from injury.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Pleioflow (Industry-sponsored)
• Locations: 1 site (Athens)
• Trial ID: NCT05662501 on ClinicalTrials.gov

What this trial studies

The Pleiades study is a non-randomized, prospective clinical trial that assesses the safety and feasibility of the Pleioflow-RF device in adult patients undergoing elective cardiac surgery. This innovative flow assist device works in conjunction with the traditional Intra Aortic Balloon (IAB) to enhance renal perfusion during low flow and pressure conditions. The study aims to determine how effectively this device can improve outcomes for patients at risk of acute kidney injury during cardiac procedures.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 85 who are scheduled for elective coronary artery bypass grafting or heart valve surgery and have specific risk factors for kidney injury.

Not a fit: Patients requiring emergency surgery or those with severe preoperative renal insufficiency are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the incidence of acute kidney injury in patients undergoing elective cardiac surgery.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving renal outcomes during cardiac surgery, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 and ≤ 85, men and women
2. Elective coronary artery bypass grafting surgery and/or heart valve surgery with planned CPB.
3. Written informed consent provided
4. Haemoglobulin (Hb) ≥ 11 g/dl in women and ≥ 12 g/dl for men
5. Ejection fraction ≥ 30%
6. 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:

1. emergency surgery
2. severe sepsis or rhabdomyolysis
3. severe preoperative renal insufficiency requiring renal replacement therapy (RRT) or even once RRT
4. receiving 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)
5. Any severe coagulopathy
6. Participation in another trial
7. Any surgical or medical condition which according to investigator's opinion could create problem in the assessment of safety and /or efficacy of the device
8. Severe comorbidity with life expectancy \< 6 months
9. History of poor compliance with previous treatment and incapability of giving informed consent
10. Pregnant 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.
11. Peripheral artery disease making insertion of IABP unfeasible
12. Preoperative intra-aortic balloon pump (IABP)
13. Preoperative other device in the same anatomical area (which could possibly create dysfunction of any of the other two devices)

Where this trial is running

Athens

• Onassis Cardiac Center — Athens, Greece (Recruiting)

Study contacts

• Principal investigator: Georgios Stavridis — Onassis Cardiac Center
• Study coordinator: Aikaterini Dimitriou

Conditions Elective Cardiac Surgery; acute kidney injury; cardiac surgery; flow assist; intra-aortic balloon pump; renal failure