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ASN / Education & Meetings / Kidney Week /
Abstract: INFO19-TH

Selective Cytopheretic Device Therapy in Cardiorenal Syndrome: Rationale and Study Design of the NEUTRALIZE-CRS Left Ventricular Assist Device (LVAD) Study

Session Information

  • Informational Posters - 1
    October 22, 2026 | Location: Exhibit Hall A, Convention Center
    Abstract Time: 10:00 AM - 12:00 PM

Category: Cardiovascular-Kidney-Metabolic Health

  • No subcategory defined

Authors

  • Yessayan, Lenar Tatios, University of Michigan Michigan Medicine, Ann Arbor, Michigan, United States
  • Catanzaro, David, SeaStar Medical Inc, Denver, Colorado, United States
  • Scribe, Emily, SeaStar Medical Inc, Denver, Colorado, United States
  • Iyer, Sai Prasad N., SeaStar Medical Inc, Denver, Colorado, United States
  • Chung, Kevin K., SeaStar Medical Inc, Denver, Colorado, United States
  • Humes, H. David, University of Michigan Michigan Medicine, Ann Arbor, Michigan, United States
Description

Cardiorenal syndrome (CRS) complicates advanced systolic heart failure and often limits eligibility for LVAD implantation due to worsening renal function and right ventricular failure (RVF). Dysregulated innate immune activation contributes to cardiac and renal dysfunction. The selective cytopheretic device (SCD) is an extracorporeal immunomodulatory therapy targeting activated neutrophils and monocytes to restore immune balance. NEUTRALIZE-CRS LVAD is a prospective, multicenter, open-label, single-arm feasibility study of adults with NYHA IIIB/IV heart failure and CRS. Patients receive daily 4-hour SCD treatments for up to 6 days using continuous renal replacement therapy. The primary outcome is safety; secondary outcomes include renal function, hemodynamics, biomarkers, and LVAD progression. Up to 20 patients will be enrolled. Assessments include safety events, renal improvement, RVF reversal, and LVAD bridging, with exploratory immune analyses. This study evaluates SCD as a bridging strategy, aiming to establish feasibility and guide future trials targeting immune dysregulation in CRS.

Figure 1: Study Schema

Funding

  • SeaStar Medical