Thoratec has enrolled the first patient in a study intended to evaluate and compare the effectiveness of the HeartMate II left ventricular assist system as a destination therapy device in heart failure patients.
The prospective, multi-centre, non-randomised, controlled and observational ROADMAP post-market study will enrol 200 patients in one of two cohorts – optimal medical management or left ventricular assist device.
The primary endpoint will be survival and functional improvement, as measured by the six-minute walk test at one year, while secondary endpoints include actuarial survival, quality of life, pump replacement, adverse events and rehospitalisation.
HeartMate II is a continuous-flow left ventricular assist device, designed to provide long-term cardiac support. It can pump up to 10l of blood per minute.