Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up
Status: Completed
Location: See all (69) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: No
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• Subject or legal representative has signed Informed Consent Form (ICF)
• Age ≥ 18 years
• BSA ≥ 1.2 m2
• NYHA Class III with dyspnea upon mild physical activity or NYHA Class IV
• LVEF ≤ 25%
• a) Inotrope dependent OR b) CI < 2.2 L/min/m2, while not on inotropes and subjects must also meet one of the following:
• On optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond
• Advanced heart failure for at least 14 days AND dependent on intra-aortic balloon pump (IABP) for at least 7 days,
• Females of child bearing age must agree to use adequate contraception
Locations
United States
Arkansas
Baptist Health Medical Center - Little Rock
Little Rock
California
Cedars Sinai Medical Center
Beverly Hills
University of California, San Diego
La Jolla
Sutter Memorial Hospital
Sacramento
Sharp Memorial Hospital
San Diego
California Pacific Medical Center
San Francisco
Stanford University
Stanford
Colorado
University of Colorado Hospital
Aurora
Connecticut
Yale New Haven Hospital
New Haven
Washington, D.c.
MedStar Washington Hospital Center
Washington
Florida
Shands Hospital @ University of Florida
Gainesville
Florida Hospital
Orlando
Tampa General Hospital
Tampa
Georgia
Emory University Hospital
Atlanta
Piedmont Heart Institute
Atlanta
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Illinois
Northwestern Memorial Hospital
Chicago
University of Chicago Medical Center
Chicago
Advocate Christ Medical Center
Oak Lawn
Indiana
IU Health/Methodist Hospital
Indianapolis
St. Vincent Hospital
Indianapolis
Kentucky
University of Kentucky - Saha Cardiovascular Research Center
Lexington
Jewish Hospital
Louisville
Louisiana
Ochsner Medical Center
New Orleans
Massachusetts
Brigham & Women's Hospital
Boston
Massachusetts General Hospital
Boston
Maryland
Johns Hopkins Unversity Hospital
Baltimore
Michigan
University of Michigan
Ann Arbor
Henry Ford Hospital
Detroit
Spectrum Health Butterworth Hospital
Grand Rapids
Minnesota
Abbott Northwestern Hospital
Minneapolis
University of Minnesota Medical Center, Fairview
Minneapolis
Mayo Clinic Rochester
Rochester
Missouri
Barnes Jewish Hospital
Saint Louis
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
Carolinas Medical Center
Charlotte
Duke University Medical Center
Durham
Nebraska
University of Nebraska Medical Center
Omaha
New Jersey
Newark Beth Israel Medical Center
Newark
New York
Montefiore Medical Center
Bronx
Columbia University Medical Center
New York
Mt. Sinai Medical Center
New York
University of Rochester Medical Center
Rochester
Ohio
Cleveland Clinic Foundation
Cleveland
University Hospitals of Cleveland
Cleveland
Ohio State University Medical Center
Columbus
Oklahoma
INTEGRIS Baptist Medical Center
Oklahoma City
Oregon
Oregon Health and Science University
Portland
Pennsylvania
Hershey
Hershey
Hospital of the University of Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
Allegheny General Hospital
Pittsburgh
University of Pittsburgh Medical Center
Pittsburgh
South Carolina
Medical University of South Carolina
Charleston
Tennessee
St. Thomas West Hospital
Nashville
Vanderbilt University Medical Center
Nashville
Texas
Baylor Research Institute
Dallas
Memorial Hermann Health Systems
Houston
Methodist Houston
Houston
Texas Heart Institute
Houston
Utah
University of Utah Hospital and Clinics
Salt Lake City
Virginia
University of Virginia Medical Center
Charlottesville
Inova Fairfax Hospital
Falls Church
Sentara Norfolk General Hospital
Norfolk
Bon Secours St. Mary's Hospital
Richmond
Virginia Commonwealth University
Richmond
Washington
University of Washington Medical Center
Seattle
Wisconsin
University of Wisconsin Hospitals and Clinics
Madison
St. Luke's Medical Center
Milwaukee
Time Frame
Start Date: August 2016
Completion Date: March 2021
Participants
Target number of participants: 1685
Treatments
Experimental: HeartMate 3 LVAS (HM3 LVAS)
The study was a single-arm, prospective, multi-center, study for continued evaluation of safety and clinical performance of the HM3 LVAS.
Authors
Sirtaz Adatya, Margarita Camacho, Allen Anderson, Brian Bruckner, Francis Pagani, Charles Klodell, Brian Lima, Scott Silvestry, David Majure, Stephen Bailey, Ryan Tedford, Jay Bhama, Shashank Desai, Igor Gregoric, Anelechi Anyanwu, John Um, Pramod Bonde, Ahmet Kilic, Francisco Arabia, Mary Keebler, Edward Soltesz, James Long, Bassam Shukrallah, Abeel Mangi, Andreas Brieke, Hassan Nemeh, Steve Singh, William Hiesinger, David D'Alessandro, John Kern, Shelley Hall, Nahush Mokadam, Mark Slaughter, Sanjeev Gulati, Gabriel Sayer, Maya Guglin, Ranjit John, Michael Givertz, Ulrich Jorde, Karol Mudy, Craig Selzman, Antone Tatooles, Claudius Mahr, Marzia Leacche, Don Chomsky, Steven Fiser, Jason Katz, Yoshifumi Naka, Leora Yarboro, Robert Adamson, Eric Skipper, Michael McGrath, Carmelo Milano, Francis Downey, Walter Pae, Masahiro Ono, Nader Moazami, Shahab Akhter, Robert Kincade, Takushi Kohmoto, Thomas Beaver, Leway Chen, Eric Adler, Akinobu Itoh, Asghar Khaghani, Farooq Sheikh, John Ransom, Brett Sheridan, Robert Kormos, Frederick Tibayan, Guilherme Oliveira, John Stulak, J. David Vega, Daniel Tang, Richard Ha, David Dean, Mary Walsh, Vigneshwar Kasirajan, Christopher Barreiro, Adrian Van Bakel, Marc Katz, Aditya Bansai, Douglas Horstmanshoff, Christiano Caldeira, Martin Streuber, Ramesh Singh, Pavan Atluri, John Entwistle III, I-Wen Wang
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices