The study objective is to gather post market clinical data in 25 patients on the use of the CentriMag RVAS when used for temporary mechanical circulatory support of the right ventricle in patients with acute right ventricular failure from any cause. Objectives studied include:
a) Duration of right ventricular support
b) Incidence of adverse effects
c) Evaluation of end-organ function
d) Evaluation of hemodynamics
e) Survival at 30 days post RVAD removal
The study hypothesis is: Survival to 30 days or hospital discharge (whichever is longer) will exceed 10% for patients who do not undergo implantation of a long-term device, OR survival to induction of anesthesia for patients who receive a transplant or long-term device.
Primary endpoint is:
In patients who recover and do not go on to transplantation or a long-term device: Survival to 30 days post-support or to hospital discharge (whichever is longer).
In patients who do not recover and are bridged to transplant or a long-term system: Survival to induction of anesthesia for implantation of a long-term device or heart transplant.
On October 11, 2008, Thoratec (formerly Levitronix) received HDE approval for use of the CentriMag RVAS in patients with acute right ventricular failure and is intended for use in patients to provide temporary circulatory support for up to 14 days and in patients with BSA > 1.4 m2.
Principal Investigator: Craig Selzman
Department: Cardiothoracic Divison