Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

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.

The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority
evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.

Inclusion Criteria:

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

- Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:

- On optimal medical management and are failing to respond; or

- In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or

- Treated with ACE inhibitors or beta-blockers and found to be intolerant.

- Ineligible for cardiac transplant

- VO2max <=14 ml/kg/min

- LVEF <=25%

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