Our Clinical Trials
In June 2007, we began enrollment in our CE Mark Trial. This trial is ongoing and evaluating the safety and patient quality of life improvements associated with device support of greater than six months.
Late-Breaking Abstract Presented at the 58th Annual Scientific Session of the American College of Cardiology (March 30, 2009) click here for press release
Proof of Concept: Hemodynamic Response to Long Term Partial Ventricular Support with the Synergy™ Micro-pump
Bart Meyns, MD, PhD1, Stefan Klotz, MD, PhD2, Andre Simon, MD3, Walter Droogne, MD1, Filip Rega MD1, Bartley Griffith, MD4, Robert Dowling, MD5, Mark J. Zucker, MD6, Daniel Burkhoff, MD, PhD7,8. 1University of Leuven, Leuven, Belgium, 2University of Muenster, Münster, Germany, 3Hannover Medical School, Hannover, Germany, 4University of Maryland, Baltimore, MD, 5Univeristy of Louisville, Louisville, KY, 6Newark Beth Israel Medical Center, Newark, NJ, 7CircuLite, Inc., Saddle Brook, NJ and 8Columbia University, New York, NY.
ABSTRACT
Background: Use of current left ventricular assist devices (VAD) that provide full circulatory support is restricted to critically ill patients because of associated risks. Smaller, less invasive devices could expand VAD use to a larger pool of less sick patients but would pump less blood, providing only partial support. This raises questions about appropriate patient selection criteria and demonstration that partial support provides long term benefits.
Methods: The Synergy™ device pumps ~3.0 L/min, is implanted (off pump) via a mini-thoracotomy and is positioned in a right subclavicular subcutaneous pocket (like a pacemaker). The inflow cannula inserts into the left atrium; the outflow graft connects to the right subclavian artery.
Results: 17 patients (14 males), age 53±9 yrs with EF 21±6%, mean arterial pressure 73±7 mmHg, PCWP 29±6 mmHg and CI 1.9±0.4 L/min/M2 were implanted. Duration of support ranged from 6-213 (median 87) days. In addition to demonstration of significant acute hemodynamic improvements in the first day of support, 9 patients underwent follow-up right heart catheterization at 10.6±6 weeks. These patients showed significant increases in arterial pressure (67±8 vs 80±9, p=0.01) and cardiac index (2.0±0.4 vs 2.8±0.6, p=0.01) with large reductions in pulmonary capillary wedge pressure (30±5 vs 18±5, p=0.001). Conclusions: Partial support appears to interrupt the progressive hemodynamic deterioration typical of late stage heart failure. If proven safe and durable, this device could be used in a relatively large population of patients with severe heart failure not sick enough to justify use of currently available full support VADs.
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