Selective Cytopheretic Device (SCD) Trial

This is an interventional treatment trial for Acute on Chronic Systolic Congestive Heart Failure focused on measuring Awaiting Left ventricular assist device implantation, Hospitalized Read More

Inclusion Criteria:

1. Primary hospitalization for acute decompensated chronic systolic heart failure

2. Potential LVAD candidate with:

   1. Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure
   2. NYHA class IIIB or IV chronic (≤ 90 days) systolic heart failure, with failure to respond to optimal medical therapy (beta blocker, ACE inhibitor or ARB or valsartan/sacubitril, aldosterone antagonist, unless not tolerated or contraindicated, and loop diuretic, as needed) for 45 of the last 60 days
   3. Known previous peak exercise oxygen consumption < 14 mL/Kg/min or if unable to exercise, dependent on an intra-aortic balloon pump, short-term mechanical circulatory support device or intravenous inotropes unless inotropes contraindicated for clinical reasons (e.g., ventricular arrhythmias)
3. Baseline eGFR** ≥ 40 ml/min/1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)

4. At least one of the following two criteria:

   1. Severe right ventricular failure (RVF), defined as meeting at least 2 of the following 4 criteria

      • Central venous pressure > 16 mmHg
      • Central venous pressure/Pulmonary wedge pressure >0.65
      • Right ventricular stroke work index < 300 mmHg * ml/m2
      • Pulmonary artery pulsatility index (PAPi) < 2,

   2. Worsening renal failure (WRF), defined for the purposes of this study as

      • Increase serum creatinine ≥ 0.5 mg/dL from baseline (baseline defined as the lowest known serum creatinine within 90 days of study enrollment) AND
      • eGFR** ≤ 30 ml/min/1.73 m2 based on serum creatinine at enrollment*** AND
      • Cardiorenal syndrome is the most likely explanation for WRF AND
      • Intolerant or inadequately responsive to standard of care diuretic therapy
5. PA catheter in place at the time of enrollment
6. PCW ≥ 20 mmHg

7. Age ≥ 21and ≤ 75 years

   • eGFR calculated using the 4-variable MDRD equation *** Recognizing that this is not a steady state creatinine

Exclusion Criteria:

1. Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status
2. Prior sensitivity to dialysis device components
3. Bacteremia
4. Temperature ≥ 101.5 F or WBC ≥ 10,000 K/uL or any patient with suspected systemic infection.
5. Active malignancy requiring chemotherapy, biological therapy or radiation therapy
6. The use of intravenous iodinated contrast agent within the prior 72 hours or the anticipated use of such an agent during SCD therapy
7. Need for intravenous vasopressor (i.e., phenylephrine, vasopressin), intravenous vasoconstricting inotrope (i.e., norepinephrine or epinephrine) or dopamine > 3 mcg/kg/min. (Note: use of vasodilating inotropes [i.e., dobutamine and milrinone] or dopamine at ≤ 3 mcg/kg/min will not preclude study inclusion)
8. Persistent SBP < 80 mmHg
9. WBC < 4000 K/uL
10. Platelets < 100,000K/uL
11. Serum creatinine > 4 mg/dL or receiving dialysis / CRRT
12. Acute coronary syndrome within the past month
13. Women who are pregnant, breastfeeding a child, or trying to become pregnant
14. Subject not able to sign informed consent, unless they have a legally authorized representative (LAR)
15. Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and/or samples are taken (i.e., no test device or test drug used) are allowed to participate
16. Use of any other investigational drug or device within the previous 30 days