PREVENtion of HeartMate II Pump Thrombosis

PREVENT is a prospective, multi-center, non-randomized study that is designed (1) to assess
the incidence of HM II pump thrombosis in the current era when recommended practices for
clinical management are adopted, and (2) to identify the risk factors associated with pump
thrombosis events. The recommended practices are focused on implantation technique,
anticoagulation regimen, pump speed and blood pressure management. All consecutive patients
receiving a HM II implant will be considered for this study.

Inclusion Criteria:

- Subject or legally authorized representative has signed an informed consent form

- Subject is receiving the HeartMate II as their first Left Ventricular Assist Device
(LVAD)

Exclusion Criteria:

- Prior mechanical circulatory support (MCS) (except for intra-aortic balloon pump)

- Participation in any other clinical investigation(s) involving a MCS device, or an
investigation(s) that is likely to confound study results or affect study outcome