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

Study Description

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.

Contact Information

Status:

Name, Phone, Email:
Kirk Volkman, NP
Jerri Housley, Research Coordinator
801-585-5122
Kirk.volkman@hsc.utah.edu
Jerri.housely@hsc.utah.edu

Principle Investigator:
Edward Michael Gilbert, M.D.

Please Note:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.

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.

Participant Eligibility

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