Rationale, Design, and Methods for a Pivotal Randomized Clinical Trial of Continuous Aortic Flow Augmentation in Patients With Exacerbation of Heart Failure: The MOMENTUM Trial

Greenberg, Barry; Czerska, Barbara; Abraham, William T.; Neaton, James D.; Delgado, Reynolds M.; Mather, Paul; Bourge, Robert; Parker, Irene C.; Konstam, Marvin A.; on behalf of the MOMENTUM Investigators and Coordinators,

doi:10.1016/j.cardfail.2007.06.728

« Previous Next »Journal of Cardiac Failure
Volume 13, Issue 9 , Pages 715-721, November 2007

Rationale, Design, and Methods for a Pivotal Randomized Clinical Trial of Continuous Aortic Flow Augmentation in Patients With Exacerbation of Heart Failure: The MOMENTUM Trial

Barry Greenberg, MD
- University of California, San Diego, San Diego, California
Barbara Czerska, MD
- Henry Ford Heart and Vascular Institute, Detroit, Michigan
William T. Abraham, MD
- The Ohio State University, Columbus, Ohio
James D. Neaton, PhD
- University of Minnesota, Minneapolis, Minnesota
Reynolds M. Delgado, MD
- Texas Heart Institute, Houston, Texas
Paul Mather, MD
- Jefferson University, Philadelphia, Pennsylvania
Robert Bourge, MD
- University of Alabama, Birmingham, Alabama
Irene C. Parker, RN
- Orqis Medical, Lake Forest, California
Marvin A. Konstam, MD
- Tufts-New England Medical Center, Boston, Massachusetts
- Reprint requests: Marvin A. Konstam, MD, Box 108, Tufts-New England Medical Center, 750 Washington St., Boston, MA 02111.
on behalf of the MOMENTUM Investigators and Coordinators

Received 24 April 2006; received in revised form 15 June 2007; accepted 18 June 2007.

Abstract

Background

For patients hospitalized with heart failure (HF) who are inadequately responsive to medical therapy, the options include ventricular assist devices and cardiac transplant. In animal models and patients, continuous aortic flow augmentation using the Orqis Medical Cancion System (Orqis Medical Corporation, Lake Forest, California), a percutaneously placed arterial-to-arterial circuit (continuous flow up to 1.5 L/min) with an extracorporeal, magnetic, centrifugal pump, improves hemodynamics and renal function with benefits persisting 24 hours after discontinuation.

Methods and Results

The Multi-center Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy is enrolling patients hospitalized with HF who are randomized to continuous aortic flow augmentation or medical therapy alone. Entry requires persistent HF, elevated pulmonary capillary wedge pressure, reduced cardiac index, and impaired renal function or substantial diuretic requirement despite intravenous inotrope or vasodilator treatment. The primary efficacy end point is a composite including the components of 72- to 96-hour pulmonary capillary wedge pressure reduction and days alive out of hospital with no mechanical support for more than 35 days. Additional end points include changes in serum creatinine, N-terminal pro-B-type natriuretic peptide, and health-related quality of life.

Conclusions

The Multi-center Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy tests the hypothesis that continuous aortic flow augmentation improves the clinical status and outcomes in patients hospitalized with HF exacerbation who are inadequately responsive to medical therapy.

Key Words: Continuous aortic flow augmentation, heart-assist device, heart failure, hemodynamics