Thoratec has enrolled first patient for its Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients (ROADMAP) study.
The controlled, multi-center, non-randomized, observational, prospective ROADMAP study is designed for HeartMate II Left Ventricular Assist System (LVAS).
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 aim is to assess and compare the effectiveness of HeartMate II support versus Optimal Medical Management (OMM).
The patients will be followed for two years.
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, adverse events, pump replacement, quality of life, and rehospitalizations.
Thoratec president and CEO Gary Burbach said they believe there is a substantial unmet need for treatment options to improve functional status and quality of life in this advanced heart failure patient population.
"We look forward to obtain new data to support MCS therapy and to better understanding the factors related to patient and physician decisions for HeartMate II therapy versus continuing OMM," Burbach said.