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Heart Care Specialty Updates

May 2015

VAD clinical trial enrolling

Enrollment is currently open for a prospective, randomized, controlled, unblinded, multicenter clinical study to evaluate stroke incidence in patients implanted with a HeartWare® ventricular assist device (VAD) (HeartWare Inc., Framingham, MA). The study compares stroke incidence in a newly enrolled cohort of subjects receiving optimal blood pressure management with the stroke incidence observed in the original pivotal clinical trial (known as the ENDURANCE trial), where optimal blood pressure management was not specified. The data will be used to seek approval for the VAD as a destination therapy. The primary investigator is Ranjit John, MD. For information, contact Dr. John at johnx008@umn.edu.

Risk factors for thrombosis with LVAD clinical trial enrolling

All University of Minnesota Heart Care patients who undergo placement of a HeartMate II® left ventricular assist device (LVAD) will be considered for a currently enrolling study called PREVENT. This prospective, multicenter, nonrandomized study will assess the incidence of pump thrombosis when recommended practices for clinical management of implanted LVADs are adopted and will identify the risk factors associated with pump thrombosis events. Recommended practices are focused on implantation technique, anticoagulation regimen, pump speed, and blood pressure management. The primary investigator is Thenappan Thenappan, MD. For information, contact Dr. Thenappan at tthenapp@umn.edu.

Next-generation VAD trial opening soon

Enrollment will soon begin for the highly anticipated HeartMate III® ventricular assist device (VAD) noninferiority clinical trial. The study seeks to demonstrate non-inferiority of the next-generation HeartMate III® VAD as compared to the HeartMate II® VAD when used for advanced, refractory, left ventricular heart failure. This study is being conducted at 60 centers in the United States. All randomized subjects will be followed for 24 months or to transplant, explant, or death, whichever occurs first. The primary investigators are Ranjit John, MD, and Rebecca Cogswell, MD. For information, contact Dr. Cogswell at cogsw014@umn.edu.

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