Abstract: INFO07-FR
NEUTRALIZE-CRS: A Multicenter, Single-Arm, Open-Label Study to Assess a Selective Cytopheretic Device in Bridging Severe Heart Failure Patients to Left Ventricular Assist Device (LVAD) Implantation
Session Information
- Informational Posters - 2
October 25, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Hypertension and CVD
- No subcategory defined
Authors
- Yessayan, Lenar Tatios, University of Michigan Medical School, Ann Arbor, Michigan, United States
- Johnston, Kimberly, Innovative BioTherapies, Inc., Ann Arbor, Michigan, United States
- Pino, Christopher, Innovative BioTherapies, Inc., Ann Arbor, Michigan, United States
- Westover, Angela, University of Michigan Medical School, Ann Arbor, Michigan, United States
- Chung, Kevin K., SeaStar Medical, Denver, Colorado, United States
- Scribe, Emily, SeaStar Medical, Denver, Colorado, United States
- Iyer, Sai Prasad N., SeaStar Medical, Denver, Colorado, United States
- Catanzaro, David, SeaStar Medical, Denver, Colorado, United States
- Humes, H. David, University of Michigan Medical School, Ann Arbor, Michigan, United States
Description
Chronic Heart Failure (CHF) is understood to be a multi-system disease process involving cardiovascular, renal, neuroendocrine and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. Chronic systemic inflammation is thought to be a key underlying factor driving the cardio-depressant effects associated with CHF.
The Selective Cytopheretic Device (SCD) is an immunomodulatory, extracorporeal device targeted to attenuate the cardio-depressant effects associated with the chronic pro-inflammatory state of CHF, and functions by selectively neutralizing activated systemic leukocytes without causing immunodepletion or immunosuppression. A first-in-human proof-of-concept of successful bridge to LVAD in an ineligible patient with severe CHF forms the basis for this larger clinical study.
This study will expand a current single center investigational device exemption (IDE) (NCT03836482) to a multi-center trial to enroll 20 patients in 4 centers. The single arm, open label study will enroll eligible patients in the ICU with acute on chronic systolic HF and worsening renal function (WRF) due to cardiorenal syndrome while awaiting LVAD implantation. Eligible patients will be treated with the SCD for 4 hours a day up to 6 days. Additionally, participants will have additional study procedures and be evaluated to determine if their kidney function improves enough to undergo LVAD implantation. The primary outcome measure is percent of patients with reversal of WRF measured within a 30-day period after final SCD treatment or LVAD. A key secondary measure will be percent of patients receiving LVAD within a 30 day period following final SCD treatment. Other measures that will be assessed are changes in renal and cardiac function following SCD treatment initiation.
NEUTRALIZE-CRS Study Design
Funding
- SeaStar Medical, NIH