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

The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation.

The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).

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