HeartMate II*
The HeartMate II Left Ventricular Assist System (LVAS) is Thoratec's next generation rotary blood pump in its family of implantable VADs (ventricular assist devices) treating advanced-stage heart disease. The HeartMate II is designed to address the need for smaller, long lasting devices that will benefit patients who require long-term cardiac support.
Following the successful completion of its Phase I Pilot Study in 2004, Thoratec was granted approval to begin a Phase II Pivotal Trial in February 2005. The HeartMate II Pivotal Trial is a multi-center evaluation of the HeartMate II LVAS for advanced-stage heart failure patients. As of January 25, 2008, enrollment in the DT arm was 479 patients, and the BTT arm of the trial reached 439 patients. In total, 918 patients have been enrolled in the pivotal trial.
The trial consists of two study arms: one for patients who are candidates for cardiac transplantation and one for patients ineligible for transplantation.
Click here for more information or to refer a patient to a HeartMate II trial site, please fill out the following.
HeartMate II LVAS animation with narration
Candidates for Cardiac Transplantation
The purpose of this study arm is to determine the safety and efficacy of the HeartMate II LVAS as a bridge-to-cardiac transplantation in late-stage heart failure patients who are listed for cardiac transplant but at imminent risk of dying. This study arm is a prospective, non-randomized evaluation in which all patients will receive the HeartMate II LVAS and will be compared with an objective performance criterion (OPC). Enrollment of 133 patients in the BTT arm of the trial was completed in May, 2006
Patients Ineligible for Transplantation
The purpose of this study arm is to assess the safety and efficacy of the HeartMate II LVAS as Destination Therapy (i.e., permanent implant) in advanced-stage heart failure patients who do not qualify for cardiac transplantation. This study arm is a prospective, randomized, unblinded evaluation in which patients will be randomly assigned to treatment with the HeartMate XVE LVAS (control group) or to treatment with the HeartMate II LVAS. Up to 40 sites will enroll a total of 200 patients, randomizing the HeartMate II LVAS to the HeartMate XVE LVAS on a 2 to 1 basis, respectively. The trial continues to enroll additional patients under a Continued Access Protocol (CAP) approval for the Destination Therapy arm.
Patients to Consider for this Study
In North America alone, the deaths of 60,000 patients are attributable to heart failure each year. Many of these patients die in the intensive care unit, where even advanced medical therapy provides no survival options. At this stage of heart failure, mechanical assistance has repeatedly shown a survival benefit.
Device Tracking
Per FDA regulations and mandate, the Thoratec devices must be tracked. Device tracking forms or cards can be found in each pump implant kit and in the stand-alone items. Please complete the information requested on the forms/cards any time a patient is implanted, discharged, has an outcome or any internal or external device is replaced.
*Caution: Investigational device for Destination Therapy limited by Federal (U.S.A.) law to investigational use.
