1,028
Participants
Start Date
September 2, 2014
Primary Completion Date
September 28, 2018
Study Completion Date
March 26, 2019
HeartMate 3 LVAS
Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure
HeartMate II LVAS
Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure
Mt. Sinai Medical Center, New York
Columbia University Medical Center, New York
Montefiore Medical Center, The Bronx
University of Rochester Medical Center, Rochester
Allegheny General Hospital, Pittsburgh
University of Pittsburgh Medical Center, Pittsburgh
Hershey, Hershey
Hospital of the University of Pennsylvania, Philadelphia
Thomas Jefferson University Hospital, Philadelphia
MedStar Washington Hospital Center, Washington D.C.
Johns Hopkins Unversity Hospital, Baltimore
Inova Fairfax Hospital, Falls Church
University of Virginia Medical Center, Charlottesville
Bon Secours St. Mary's Hospital, Richmond
Virginia Commonwealth University, Richmond
Sentara Norfolk General Hospital, Norfolk
University of North Carolina at Chapel Hill, Chapel Hill
Duke University, Durham
Carolinas Medical Center, Charlotte
Medical University of South Carolina, Charleston
Piedmont Heart Institute, Atlanta
Emory University Hospital, Atlanta
Shands Hospital @ University of Florida, Gainesville
Florida Hospital, Orlando
Tampa General Hospital, Tampa
St. Thomas West Hospital, Nashville
Vanderbilt University Medical Center, Nashville
Jewish Hospital, Louisville
University of Kentucky - Saha Cardiovascular Research Center, Lexington
Ohio State University Medical Center, Columbus
University Hospitals of Cleveland, Cleveland
Cleveland Clinic Foundation, Cleveland
IU Health/Methodist Hospital, Indianapolis
St. Vincent Hospital, Indianapolis
University of Michigan, Ann Arbor
Henry Ford Hospital, Detroit
Spectrum Health Butterworth Hospital, Grand Rapids
University of Iowa Hospitals and Clinics, Iowa City
St. Luke's Medical Center, Milwaukee
University of Wisconsin Hospitals and Clinics, Madison
Abbott Northwestern Hospital, Minneapolis
University of Minnesota Medical Center, Fairview, Minneapolis
Mayo Clinic Rochester, Rochester
Advocate Christ Medical Center, Oak Lawn
Northwestern Memorial Hospital, Chicago
University of Chicago Medical Center, Chicago
Barnes Jewish Hospital, St Louis
University of Nebraska Medical Center, Omaha
Ochsner Medical Center, New Orleans
Baptist Health Medical Center - Little Rock, Little Rock
INTEGRIS Baptist Medical Center, Oklahoma City
Baylor Research Institute, Dallas
Memorial Hermann Health Systems, Houston
Methodist Houston, Houston
Texas Heart Institute, Houston
University of Colorado Hospital, Aurora
University of Utah Hospital and Clinics, Salt Lake City
Cedars Sinai Medical Center, Beverly Hills
University of California, San Diego, La Jolla
Sharp Memorial Hospital, San Diego
California Pacific Medical Center, San Francisco
Stanford University, Stanford
Sutter Memorial Hospital, Sacramento
Oregon Health and Science University, Portland
University of Washington Medical Center, Seattle
Yale New Haven Hospital, New Haven
Massachusetts General Hospital, Boston
Brigham & Women's Hospital, Boston
Newark Beth Israel Medical Center, Newark
Lead Sponsor
Thoratec Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY