Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation
Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation
The Company's proprietary products are based on Orqis Medical's hypothesis, supported by
 early clinical data, that increasing and maintaining continuous blood flow in the descending
 aorta, known as continuous aortic flow augmentation or CAFA, improves hemodynamics in heart
 failure patients. The clinical impact of the hemodynamic improvement is currently being
 evaluated to determine the effects of CAFA on stopping or reversing the progression of heart
 failure through three physiological effects:

 -  VASCULAR - Reducing systemic vascular resistance

 -  RENAL - Improving renal function

 -  CARDIAC - Reducing cardiac workload
Inclusion Criteria:

 1. Patients hospitalized due to decompensated heart failure who require IV inotropic
 and/or vasodilator and diuretic therapy

 2. Patients receiving appropriate medical therapy for heart failure, defined as ACE
 inhibitors and beta blockers (all unless not tolerated or contraindicated) and
 diuretics, for 1 month prior to study entry

 3. For at least 24 hours prior to inclusion into the study, the patient should be treated
 with a minimum dose of the following: dobutamine 2.5μg/kg/min or milrinone
 0.3μg/kg/min or dopamine 5μg/kg/min. or nesiritide 0.01μg/kg/min or nitroglycerin 0.3
 µg/kg/min or nitroprusside 0.3 µg/kg/min or a combination of any of these agents, with
 diuretic therapy. Doses of the above stated medications should be stable for 6 hours
 prior to inclusion into study. An increase in this dosage within the first 8 hours
 after enrollment is determined by the attending physician to be unlikely and the
 following definition of "not responding adequately to IV inotropic and/or vasodilator
 and diuretic therapy" is exhibited:

 -  PCWP is ≥ 20 mmHg at time of randomization and PCWP was ≥ 18 mmHg continuously
 for 24 hours or PCWP ≥ 20 mmHg continuously for 12 hours prior to randomization.

 -  Cardiac Index < 2.4 L/min/m2

 -  There is evidence for abnormal renal function and/or diuretic resistance defined
 as: Serum creatinine > 1.2 mg/dL or Diuretic dosage of intravenous Furosemide ≥
 120 mg daily, or equivalent

 4. LVEF < 35%

 5. Male or female 18-90 years of age

 6. If female, no child-bearing potential or negative pregnancy test

 7. Written informed consent

 8. Willingness to participate in required follow-up exams

 Exclusion Criteria:

 1. Acute Q-wave myocardial infarction within past 7 days

 2. Post cardiotomy shock within past 30 days

 3. Cardiac surgery within past 14 days

 4. Bridge to transplant

 5. History of severe COPD as defined as FEV1 < 1.0 liter

 6. History of malignant arrhythmias defined as either:

 -  sustained ventricular tachycardia > 15 beats or more in length, not associated
 with a correctable cause, within the preceding 3 months, unless the patient
 presently has an implantable cardiac defibrillator.

 -  history of ventricular fibrillation or sudden death, unless the patient presently
 has an implantable cardiac defibrillator

 7. Patients implanted with a resynchronization device within the previous 14 days or if
 there is a possibility of implant within 60 days following randomization

 8. Systolic pressure <80 mmHg

 9. Requiring cardiopulmonary support type devices

 10. Platelets < 50,000/mm3 or other evidence of coagulopathy, INR greater than 1.5 in the
 absence of anticoagulation therapy.

 11. Infection (WBC ≥ 12.5 x 103/ml, and or temperature ≥ 100.5°F/38°C)

 12. History of cerebral vascular accident (CVA) or transient ischemic attacks (TIA) within
 the last 3 months

 13. Unwilling or unable to receive blood transfusion

 14. Inability to undergo treatment with heparin

 15. Patients on dialysis or serum creatinine > 4.0 mg/dl

 16. Primary liver disease with bilirubin, SGOT, or SGPT > 4X upper limit of normal

 17. Life expectancy from other disease < 12 months

 18. Patients who are active on the cardiac transplantation waiting list, unless there is a
 documented reason (large body habitus, highly sensitized, O blood group) to anticipate
 that transplant is unlikely within the subsequent 65 days.

 19. Symptomatic patent foramen ovale or intracardiac shunt

 20. Patients diagnosed with clinically significant peripheral vascular disease, defined as
 absent pedal pulse or signs or symptoms of limb ischemia, including a history of
 intermittent claudication

 21. Patients with amyloidosis, thyroid induced heart failure, high output failure
 secondary to an arterio-venous fistula, and significant uncorrected primary valvular
 disease (with the exception of mitral regurgitation believed secondary to LV
 dilatation)