Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation

NCT00357591 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2009-12-25

No results posted yet for this study

Summary

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

Conditions

  • Heart Failure, Congestive

Interventions

DEVICE

Continuous Aortic Flow Augmentation

1.0-1.5 lpm augmented blood flow

Sponsors & Collaborators

  • Orqis Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Barry H Greenberg, M.D. · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00357591 on ClinicalTrials.gov