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

The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation

The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying.

The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.

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.