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Study 1 of 1 for search of: | "Orqis Medical Corporation" [Exact] |
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Sponsored by: |
Orqis Medical Corporation |
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Information provided by: | Orqis Medical Corporation |
ClinicalTrials.gov Identifier: | NCT00357591 |
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:
Condition | Intervention |
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Heart Failure, Congestive |
Device: Continuous Aortic Flow Augmentation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | MOMENTUM: Multicenter Trial of the Orqis Medical CRS for the Enhanced Treatment of CHF Unresponsive to Medical Therapy |
Estimated Enrollment: | 200 |
Study Start Date: | September 2004 |
Study Completion Date: | January 2008 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Control: Active Comparator |
Device: Continuous Aortic Flow Augmentation
1.0-1.5 lpm augmented blood flow
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
History of malignant arrhythmias defined as either:
United States, California | |
University of California at San Diego | |
San Diego, California, United States, 92103 |
Principal Investigator: | Barry H Greenberg, M.D. | University of California, San Diego |
Responsible Party: | Orqis Medical Corporation ( Irene Parker/VP Regulatory Affairs ) |
Study ID Numbers: | IDEG020301 |
Study First Received: | July 25, 2006 |
Last Updated: | January 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00357591 |
Health Authority: | United States: Food and Drug Administration |
Heart Failure Acute Decompensation Chronic Heart Failure |
Heart Failure Heart Diseases |
Cardiovascular Diseases |