Home » News » Clinical Intelligence » Thoratec enrolls first patient in two year ROADMAP study

Thoratec enrolls first patient in two year ROADMAP study

Thursday, November 3, 2011

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.

Looking for more news, check out the new FREE CenterWatch Weekly!

The new FREE CenterWatch Weekly is your source of critical news, emerging trends, and business issues around everything in the rapidly changing clinical research marketplace. Check out our new CWWeekly page! Sign up today for your free email newsletter, update your bookmarks and check us out regularly! We look forward to bringing you the best news and information about clinical research in 2018!