200
Participants
Start Date
October 31, 2011
Primary Completion Date
March 31, 2016
Study Completion Date
June 30, 2016
HM II (HeartMate II LVAD)
The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.
OMM (Optimal Medical Management)
Optimal medical management per established heart failure guidelines for this subject population including ACE inhibitors, beta blockers and aldosterone antagonists 45 out of the last 60 days or an inability to tolerate neurohormonal antagonists.
Mt. Sinai Medical Center, New York
Columbia University Medical Center, New York
Montefiore Medical Center, The Bronx
Hudson Valley Heart Center, Poughkeepsie
University of Rochester Medical Center, Rochester
Penn State Milton Hershey Medical Center, Hershey
Abington Memorial Hospital, Abington
Hospital of the University of Pennsylvania, Philadelphia
Inova Fairfax Hospital, Falls Church
Virginia Heart, Falls Church
Virginia Commonwealth University, Richmond
University of North Carolina, Chapel Hill
Duke University Medical Center, Durham
Emory University Hospital, Atlanta
St. Joseph's Hospital / Atlanta, Atlanta
Tampa General Hospital, Tampa
Shands Hospital at University of Florida, Gainesville
Jewish Hospital, Louisville
Ohio State University Medical Center, Columbus
Riverside Methodist Hospital, Columbus
The Metro Health System, Cleveland
Cleveland Clinic Foundation, Cleveland
St. Vincent's Hospitals and Health Services, Indianapolis
Michigan Heart, Ypsilanti
Henry Ford Hospital, Detroit
St. Luke's Medical Center, Milwaukee
Minneapolis Heart Institute Foundation, Minneapolis
University of Minnesota Medical Center, Minneapolis
Mayo Clinic Rochester, Rochester
Sanford Medical Center, Fargo
Advocate Christ Medical Center, Oak Lawn
University of Chicago Medical Center, Chicago
Barnes Jewish Hospital, St Louis
St. Luke's Hospital of Kansas City, Kansas City
Baptist Medical Center, Little Rock
INTEGRIS Baptist Medical Center, Inc., Oklahoma City
St. John Medical Center, Tulsa
Baylor University Medical Center, Dallas
Memorial Hermann, TMC, Houston
Methodist Hospital, Houston
Texas Heart Institute, Houston
University of Utah Medical School, Salt Lake City
New Mexico Heart Institute, Albuquerque
Keck Medical Center of USC, Los Angeles
Cedars Sinai Medical Center, Beverly Hills
Sharp Memorial Hospital, San Diego
Stanford University, Stanford
Oregon Health and Science University, Portland
University of Washington Medical Center, Seattle
Yale New Haven Hospital, New Haven
Newark Beth Israel Medical Center, Newark
Mercer Bucks Cardiology, Robbinsville
Lead Sponsor
Thoratec Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY