Clinical Trials

Multicenter Trial of the Orqis Medical CRS for the Enhanced Treatment of CHF Unresponsive to Medical Therapy (MOMENTUM STUDY)

Description

Status: Open to Enrollment

Start Date: Jan 01 2010

End Date: OPEN

The purpose of this study is to compare the safety and additive effectiveness of the CANCION® system used in conjunction with inotropic and or vasodilator and diuretic therapy for the treatment of acute decompensated heart failure in the chronic heart failure population not adequately responding to standard of care therapy.

The Orqis Medical Cancion Cardiac Recovery System (CRS) is intended to unload and rest the heart, while temporarily assisting in the perfusion of the organs and tissues of the body and is the investigational device being studied in this in-patient clinical trial.

Participant Eligibility

  1. Inclusion Criteria:
  2. Age Range: Male or female 18-90 years of age
  3. Patients hospitalized due to decompensated heart failure that require IV inotropic and/or vasodilator and diuretic therapy and are not adequately responding to therapy.
  4. LVEF < 35%
  5. Patients on dialysis or serum creatinine > 4.0 mg/dl.
  6. Acute Q-wave myocardial infarction within past 7 days.
  7. Post cardiogenic shock within past 30 days.
  8. History of severe COPD as defined as FEV1 < 1.0 liter.
  9. Unwilling or unable to receive blood transfusion.
  10. Patients on dialysis or serum creatinine > 4.0 mg/dl.
  1. Exclusion Criteria:
  2. Patients on dialysis or serum creatinine > 4.0 mg/dl.
  3. Acute Q-wave myocardial infarction within past 7 days.
  4. Post cardiogenic shock within past 30 days.
  5. History of severe COPD as defined as FEV1 < 1.0 liter.
  6. Unwilling or unable to receive blood transfusion.
  7. Patients on dialysis or serum creatinine > 4.0 mg/dl.

How Long Does the Study Run?

Until 200 patients are enrolled - nationwide

Location(s) of the Clinical Trial

University of Health Sciences Outpatient Clinic #10

Principal Investigators

Edward Michael Gilbert, M.D.

Contact Information

Name: Kirk
Phone:
Email: Kirk.volkman@hsc.utah.edu

Please Note:

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Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.

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