Actively Recruiting
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Led by SeaStar Medical · Updated on 2026-03-31
20
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
Sponsors
S
SeaStar Medical
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the 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. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder. This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to Left Ventricular Assist Device (LVAD) implantation who were previously deemed ineligible for this life sustaining procedure. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal membrane device targeted to modulate the cardiodepressant effects assocaited with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show that SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model. This study will enroll 20 patients across up to 5 clinical sites to evaluate the safety and initial efficacy data of SCD treatment in this indication. Patients will receive 4-hour daily SCD treatment for up to 6 days, followed by 6 months of follow up.
CONDITIONS
Official Title
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years and older.
- Evidence of systemic inflammation with blood CRP 4.5 mg/L or IL-6 5.0 pg/ml or neutrophil to lymphocyte ratio 3.0.
- Hospitalization for acute decompensated chronic systolic heart failure.
- Potential LVAD candidate with left ventricular ejection fraction 25% (for destination therapy) or 35% (for bridge to transplantation) confirmed by imaging.
- NYHA class IIIB or IV chronic systolic heart failure for 90 days, unresponsive to optimal medical therapy for 45 of the last 60 days.
- Known peak exercise oxygen consumption less than 14 mL/Kg/min or dependent on mechanical support or intravenous inotropes.
- Baseline eGFR 40 ml/min/1.73 m2 within 90 days of enrollment.
- Severe right ventricular failure defined by at least two specific hemodynamic criteria, or worsening renal failure defined by increased serum creatinine 0.5 mg/dL, low eGFR ( 30 ml/min/1.73 m2), cardiorenal syndrome as cause, and intolerance or poor response to diuretic therapy.
- Pulmonary artery catheter in place at enrollment.
- Pulmonary capillary wedge pressure 20 mmHg.
You will not qualify if you...
- Contraindications to LVAD therapy unlikely to improve with renal or volume status.
- Prior sensitivity to dialysis device components.
- Active bacteremia or suspected systemic infection with fever or high white blood cell count.
- Metastatic cancer requiring palliative treatment.
- Need for intravenous vasopressors or high-dose vasoconstricting inotropes.
- Requirement for mechanical ventilatory support.
- Need for total parenteral nutrition during treatment.
- Persistent low systolic blood pressure below 80 mmHg.
- Low white blood cell or platelet counts.
- Serum creatinine above 4 mg/dL or dialysis dependency.
- Recent acute coronary syndrome within the past month.
- Pregnancy, breastfeeding, or trying to become pregnant.
- Concurrent enrollment in another interventional clinical trial or recent use of investigational drugs or devices.
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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