Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
NCT ID: NCT00121485
Last Updated: 2022-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2005-02-28
2012-01-31
Brief Summary
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The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
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Detailed Description
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The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HeartMate II
Implantation of HeartMate II LVAS
Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
HeartMate XVE
Implantation of HeartMate XVE LVAS
Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
Interventions
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Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
* On optimal medical management and are failing to respond; or
* In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
* Treated with ACE inhibitors or beta-blockers and found to be intolerant.
* Ineligible for cardiac transplant
* VO2max \<=14 ml/kg/min
* LVEF \<=25%
Exclusion Criteria
* Evidence of, or risk factors for end-organ dysfunction that would make LVAS implantation futile
* Existence of factors that would adversely affect patient survival or function of the LVAS
* Intolerance to anticoagulant or antiplatelet therapies.
* Existence of any ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation.
* Participation in any other clinical investigation that is likely to confound study results or affect study outcome
18 Years
ALL
No
Sponsors
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Thoratec Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Pooja Chatterjee
Role: STUDY_DIRECTOR
Thoratec Corporation
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
Sharp Memorial Hospital
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado Hospital
Denver, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Shands Hospital @ University of Florida
Gainesville, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Methodist Hospital
Indianapolis, Indiana, United States
Jewish Hospital
Louisville, Kentucky, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Tufts / New England Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Barnes-Jewish Hospital/Washington University
St Louis, Missouri, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
New York Columbia Presbyterian Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
Milton Hershey Medical Center
Hershey, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Hospital of University of PA
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Baptist Memorial Hospital
Memphis, Tennessee, United States
Medical City Hospital Dallas
Dallas, Texas, United States
Texas Heart Institute
Houston, Texas, United States
LDS Hospital (Intermountain Health Care)
Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
University of Wisconsin Medical School
Madison, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Toronto General Hospital
Toronto, Ontario, Canada
Hospital Royal Victoria / McGill University Health Centre
Montreal, Quebec, Canada
Countries
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References
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Slaughter MS, Rogers JG, Milano CA, Russell SD, Conte JV, Feldman D, Sun B, Tatooles AJ, Delgado RM 3rd, Long JW, Wozniak TC, Ghumman W, Farrar DJ, Frazier OH; HeartMate II Investigators. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51. doi: 10.1056/NEJMoa0909938. Epub 2009 Nov 17.
Petrucci RJ, Rogers JG, Blue L, Gallagher C, Russell SD, Dordunoo D, Jaski BE, Chillcott S, Sun B, Yanssens TL, Tatooles A, Koundakjian L, Farrar DJ, Slaughter MS. Neurocognitive function in destination therapy patients receiving continuous-flow vs pulsatile-flow left ventricular assist device support. J Heart Lung Transplant. 2012 Jan;31(1):27-36. doi: 10.1016/j.healun.2011.10.012.
Park SJ, Milano CA, Tatooles AJ, Rogers JG, Adamson RM, Steidley DE, Ewald GA, Sundareswaran KS, Farrar DJ, Slaughter MS; HeartMate II Clinical Investigators. Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy. Circ Heart Fail. 2012 Mar 1;5(2):241-8. doi: 10.1161/CIRCHEARTFAILURE.111.963991. Epub 2012 Jan 26.
Brisco MA, Sundareswaran KS, Milano CA, Feldman D, Testani JM, Ewald GA, Slaughter MS, Farrar DJ, Goldberg LR; HeartMate II Clinical Investigators. Incidence, risk, and consequences of atrial arrhythmias in patients with continuous-flow left ventricular assist devices. J Card Surg. 2014 Jul;29(4):572-80. doi: 10.1111/jocs.12336. Epub 2014 Apr 18.
Other Identifiers
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TC010230-2
Identifier Type: -
Identifier Source: org_study_id
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