Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation

The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains
blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic
root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and
control of the pump are delivered through a percutaneous cable from the pump to the belt-worn
System Driver. Patient outcomes will be compared to objective performance criteria based on
historical data from other Thoratec implantable ventricular assist devices.

Inclusion Criteria:

The following are general criteria; more specific conditions are included in the study
protocol:

- Listed for cardiac transplantation

- NYHA Class IV heart failure symptoms

- On inotropic support, if tolerated

- Despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic
shock

Exclusion Criteria:

The following are general criteria; more specific conditions are included in the study
protocol:

- Evidence of, or risk factors for end-organ dysfunction that would make LVAS
implantation futile

- Existence of factors that would adversely affect patient survival or function of the
LVAS.

- Intolerance to anticoagulant or antiplatelet therapies.

- Existence of any ongoing mechanical circulatory support other than intra-aortic
balloon counterpulsation.

- Participation in any other clinical investigation that is likely to confound study
results or affect study outcome.