Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation

Study Overview
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Brief Summary
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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

Official Title
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MOMENTUM: Multicenter Trial of the Orqis Medical CRS for the Enhanced Treatment of CHF Unresponsive to Medical Therapy

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: Continuous Aortic Flow Augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized due to decompensated heart failure who require IV inotropic and/or vasodilator and diuretic therapy 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 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 LVEF < 35% Male or female 18-90 years of age If female, no child-bearing potential or negative pregnancy test Written informed consent Willingness to participate in required follow-up exams Exclusion Criteria: Acute Q-wave myocardial infarction within past 7 days Post cardiotomy shock within past 30 days Cardiac surgery within past 14 days Bridge to transplant History of severe COPD as defined as FEV1 < 1.0 liter 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 Patients implanted with a resynchronization device within the previous 14 days or if there is a possibility of implant within 60 days following randomization Systolic pressure <80 mmHg Requiring cardiopulmonary support type devices Platelets < 50,000/mm3 or other evidence of coagulopathy, INR greater than 1.5 in the absence of anticoagulation therapy. Infection (WBC ≥ 12.5 x 103/ml, and or temperature ≥ 100.5°F/38°C) History of cerebral vascular accident (CVA) or transient ischemic attacks (TIA) within the last 3 months Unwilling or unable to receive blood transfusion Inability to undergo treatment with heparin Patients on dialysis or serum creatinine > 4.0 mg/dl Primary liver disease with bilirubin, SGOT, or SGPT > 4X upper limit of normal Life expectancy from other disease < 12 months 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. Symptomatic patent foramen ovale or intracardiac shunt 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 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Device: Continuous Aortic Flow Augmentation<br>* 1.0-1.5 lpm augmented blood flow<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alive, Number of days out of the hospital, not on mechanical assistance over 35 day period. |  | 35 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Acute Decompensation, Chronic Heart Failure