Thoratec enrolls first patient in two year ROADMAP study

Thursday, November 3, 2011 09:21 AM

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.

Share:          
CWWeekly

April 27

Doctors, patients in the U.S. and U.K. agree: Mobile health apps are good for our health

AARP teams with Georgia Tech's HomeLab, Pfizer and UnitedHealthcare to test wearables with consumers 50+

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the March issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

Already a subscriber?
Log in to your digital subscription.

Purchase the February issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs