Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes

Launched by 3IVE LABS · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the JuxtaFlow® Renal Assist Device (RAD), which aims to help patients with kidney problems during heart surgery. When patients with renal impairment have heart surgery, they are at a higher risk of worsening kidney function, which can lead to longer hospital stays and other serious health issues. The JuxtaFlow device works by gently applying pressure to help the kidneys filter blood more effectively during surgery, which may protect them from stress and damage.

To participate in this study, individuals must be between 22 and 85 years old and scheduled for heart surgery, such as bypass surgery or valve repair, with certain levels of kidney function. Participants will need to provide consent and meet specific health criteria, such as not having certain infections or prior heart surgeries in the last six months. Those involved in the trial will receive the JuxtaFlow device during their surgery and will be monitored to see how it affects their kidney function. This research is crucial as it could lead to better outcomes for patients undergoing cardiac procedures who also have kidney issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• To be eligible for participation in this study, an individual must meet all the following criteria:
• • 1. A candidate for elective or urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
• • 2. Male or Female age 22 to 85 years
• • 3. Estimated glomerular filtration rate (eGFR) 15 - 60 mL/min/1.73m2
• • 4. Signed and dated informed consent
• 5. Female patients of childbearing potential must:
• • 1. have negative pregnancy test at the informed consent visit,
• • 2. be using previously initiated approved and effective contraception from the informed consent visit through completion of the study \*The only recommended contraception is condoms.
• Exclusion Criteria:
• An individual who meets any of the following criteria will be excluded from participation in this study:
• • 1. Any individual, or their legally authorized representative (LAR), who does not understand the requests and risks of participating in the clinical trial or is unable to give informed consent
• • 2. Pregnancy or lactation
• • 3. Prior cardiac surgery within the last 6 months
• • 4. Hemodynamic instability as determined by the Principal Investigator
• • 5. Immunosuppression
• • 6. Active infections (e.g. HIV, Tbc, and all types of Hepatitis)
• • 7. History of polycystic kidney disease
• • 8. Patients with only one active kidney or one poorly functioning kidney
• • 9. Evidence of current kidney obstruction (e.g., Kidney stones)
• • 10. Evidence of current hydronephrosis
• • 11. Active upper and/or lower urinary tract infections
• • 12. Malignancy; oncological Surgery within 5 years or ongoing antitumoral treatment
• • 13. Ongoing sepsis or endocarditis
• • 14. Patients who have an expected 30-day postoperative mortality greater than 10% as determined by the Principal Investigator
• • 15. Any secondary condition as determined by the investigator that would place the subject at an increased risk or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals; or severe BPH
• • 16. Unexplained/unexpected gross hematuria as determined by the Investigator
• • 17. Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial
• • 18. Patients who have a current unrepaired ureteral avulsion as determined by the investigator
• • 19. Patients otherwise contraindicated for urological interventions, including ureter guidewire placement via bladder cystoscopy and ureteral catheterization, or otherwise contraindicated for any of the other study procedures