1,252
Participants
Start Date
April 13, 2021
Primary Completion Date
March 31, 2026
Study Completion Date
October 31, 2027
Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®
Impella CP / Impella CP with SmartAssist will be used in most patients randomized to the Impella arm. Impella 2.5 may be used in patients with small body size (BMI \<20 kg/m2 or body weight \<60 kg) or if the iliofemoral vasculature is able to accommodate the smaller Impella 2.5 device but not the Impella CP device.
IABP Intra-aortic balloon pump
IABP uses counterpulsation to provide 0.2L/min coronary flow
Inselspital Bern, Bern
Luzerner Kantonsspital, Lucerne
Istituto Cardiocentro Ticino, Lugano
NYU Langone Health, New York
Icahn School of Medicine at Mt. Sinai, New York
Columbia University Medical Cenrer/NYPH, New York
Northwell University Hospital, Manhasset
St. Francis Hospital and Heart Center, Roslyn
Stony Brook University Hospital (SUNY), Stony Brook
Berlin CBF, Berlin
CVK Berlin, Berlin
University at Buffalo/Kaleida Health, Buffalo
Allegheny General Hospital, Pittsburgh
WellSpan York Hospital, York
Klinikum Karlsburg, Karlsburg
Sentara Norfolk Health System, Norfolk
Carilion Clinic, Roanoke
West Virginia University Hospital, Morgantown
Wake Forest University Health Sciences, Winston-Salem
North Carolina Heart and Vascular Research, Raleigh
Duke University, Durham
Sanger Heart and Vascular Institute, Charlotte
Greenville Hospital System, Greenville
Northside Cardiovascular Institute, Lawrenceville
Emory University Hospital, Atlanta
UF Health Jacksonville, Jacksonville
The Cardiac & Vascular Institute, Gainesville
University of Florida Health - Gainesville, Gainesville
University of Alabama, Birmingham
Universitätsklinikum Gießen, Giessen
Centennial Heart - Nashville, Nashville
Ascension St. Thomas West, Nashville
Vanderbilt University Medical Center, Nashville
Wellmont Cardiology Services, Kingsport
Universitätsklinikum Düsseldorf, Düsseldorf
University Hospitals Cleveland Medical Center, Cleveland
Linder Research Center (The Christ Hospital), Cincinnati
Henry Ford Hospital, Detroit
Henry Ford St. John Hospital, Detroit
Corewell Health, Grand Rapids
St. Vinzenz-Hospital GMBH KÖLN, Cologne
University Hospital Aachen, Aachen
Aurora St. Luke's Medical Center, Milwaukee
Medical College of Wisconsin, Milwaukee
Krankenhaus der Barmherzigen Brüder, Trier
Metropolitan Heart and Vascular Institute / Metropolitan Cardiology Consultants, Coon Rapids
CentraCare (St. Cloud Hospital), Saint Cloud
NorthShore University Health System, Evanston
Northwestern University, Evanston
Advocate Christ Medical Center, Oak Lawn
Rush University Medical Center, Chicago
SSM Health DePaul Hospital, Bridgeton
St. Luke's Hospital, Kansas City
Cardiovascular Research Institute of Kansas, Wichita
Ochsner Foundation Hospital, New Orleans
Arkansas Cardiology, Little Rock
University of Oklahoma Medical Center, Oklahoma City
Baylor Scott & White Heart - Plano, Plano
Presbyterian Hospital Dallas / Texas Health Physicians Group, Dallas
Medical City Fort Worth, Fort Worth
HCA Houston Healthcare, Houston
Houston Methodist Hospital, Houston
Memorial Hermann Texas Medical Center (UT Health), Houston
Texas Heart Institute at Baylor St. Luke's Hospital, Houston
Texas Cardiology Associates of Houston, Kingwood
Methodist Hospital - San Antonio, San Antonio
Universitätsklinikum Freiburg, Universitäts-Herzzentrum, Bad Krozingen
Colorado Heart and Vascular, Lakewood
Klinikum rechts der Isar der TUM, Munich
St. Joseph's Medical Center - Phoenix, Phoenix
Northwest Medical Center Tucson, Tucson
Lovelace/New Mexico Heart Institute, Albuquerque
Klinikum Friedrichshafen GmbH, Friedrichshafen
Keck School of Medicine of USC, Los Angeles
Universitätsklinikum Erlangen, Erlangen
Adventist Health Glendale, Glendale
UCSD Medical Center, San Diego
Loma Linda University Health, San Bernardino
St. Joseph Hospital - Orange, Orange
Uniklinik Würzburg, Würzburg
Providence St. Vincent Medical Center, Portland
University Of Washington Medical Center, Seattle
Hartford Hospital, Hartford
Tufts Medical Center, Boston
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center, Boston
Catholic Medical Center, Manchester
Englewood Hospital, Englewood
Hackensack University Medical Center, Hackensack
Morristown Medical Center, Morristown
Jersey Shore University Medical Center, Neptune City
The Valley Hospital - Ridgewood, Ridgewood
Montefiore Medical Center - Moses, The Bronx
Toronto General Hospital, Toronto
University Hopsital Frankfurt, Frankfurt
Ospedale di San Donato, San Donato Milanese
Royal Brompton Hospital, London
Royal Victoria Hospital, Montreal
Klinikum Chemnitz gGmbH, Chemnitz
Herzzentrum Dresden GmbH, Dresden
Policlinico Universitario Agostino Gemelli, Rome
Catharina Ziekenhuis Eindhoven, Eindhoven
Lead Sponsor
Abiomed Inc.
INDUSTRY