Thoratec has enrolled the first patient into the ROADMAP (risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients) study. The patient was enrolled at INTEGRIS Baptist Medical Center in Oklahoma City.
ROADMAP is a post-market study of the HeartMate IIR Left VentricularAssist System (LVAS) as a destination therapy device. The study will involve ambulatory advanced heart failure patients who are not yet dependent on intravenous inotropic support and are typically categorized as INTERMACS profiles 4-6, within the existing FDA-approved indication for destination therapy. The primary objective of the prospective, multi-center, non-randomized, controlled, observational study is to evaluate and compare the effectiveness of HeartMate II support versus Optimal Medical Management (OMM).
Subjects will be enrolled in one of two cohorts: OMM or LVAD. Clinical investigators and the patients will decide which cohort a patient will enter based on the center's standard of care and patient acceptance of therapy options. Baseline risk assessment profiles will allow for stratification of expected risk and severity of illness. The study will include 200 patients at up to 50 sites, including experienced HeartMate II implant centers as well as community centers that care for a large volume of advanced heart failure patients.
Patients will be followed for two years, and the primary endpoint will be a composite of survival and functional improvement, as measured by the six-minute walk test, at one year. Secondary endpoints include actuarial survival, quality of life, pump replacement, adverse events and rehospitalizations.