Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy
1 other identifier
interventional
200
2 countries
47
Brief Summary
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac transplantation. The Destination Therapy indication for use was approved by FDA on January 20, 2010 (ref. PMA P060040/S005).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2005
Longer than P75 for not_applicable
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 12, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
October 29, 2013
CompletedJune 27, 2022
June 1, 2022
4.3 years
July 12, 2005
November 13, 2012
June 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Endpoint
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
Patients' status at 2 years post-implant
Secondary Outcomes (14)
Minnesota Living With Heart Failure Questionnaire(MLWHF)
Baseline, Months 1,3,6,12
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Baseline, Months 1, 3, 6, 12
New York Heart Association (NYHA) Classification
Baseline, Months 1, 6, 12
Six Minute Walk Test (6MWT)
Baseline, Months 1, 3, 6, 12
Functional Status (Patient Activity Score)
Baseline, Months 1, 3, 6, 12
- +9 more secondary outcomes
Study Arms (2)
HeartMate II
EXPERIMENTALImplantation of HeartMate II LVAS
HeartMate XVE
ACTIVE COMPARATORImplantation of HeartMate XVE LVAS
Interventions
Implantation of left ventricular assist device for hemodynamic support
Eligibility Criteria
You may qualify if:
- The following are general criteria; more specific conditions are included in the study protocol:
- 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%
You may not qualify if:
- The following are general criteria; more specific conditions are included in the study protocol:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Medical Deviceslead
- Thoratec Corporationcollaborator
Study Sites (47)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Sharp Memorial Hospital
San Diego, California, 92123, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of Colorado Hospital
Denver, Colorado, 80262, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Shands Hospital @ University of Florida
Gainesville, Florida, 32610, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Methodist Hospital
Indianapolis, Indiana, 46206, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Tufts / New England Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Barnes-Jewish Hospital/Washington University
St Louis, Missouri, 63110, United States
Bryan LGH Heart Institute
Lincoln, Nebraska, 68516, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
New York Columbia Presbyterian Medical Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43212, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Milton Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
Hospital of University of PA
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Medical City Hospital Dallas
Dallas, Texas, 75230, United States
Texas Heart Institute
Houston, Texas, 77030, United States
LDS Hospital (Intermountain Health Care)
Salt Lake City, Utah, 84143, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23510, United States
University of Washington
Seattle, Washington, 98195, United States
Sacred Heart Medical Center
Spokane, Washington, 99204, United States
University of Wisconsin Medical School
Madison, Wisconsin, 53792, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Hospital Royal Victoria / McGill University Health Centre
Montreal, Quebec, H3A 1A1, Canada
Related Publications (4)
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.
PMID: 19920051RESULTPetrucci 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.
PMID: 22153550RESULTPark 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.
PMID: 22282104RESULTBrisco 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.
PMID: 24750460DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Poornima Sood, MD, MBA, Sr. Director, Clinical Affairs
- Organization
- Thoratec Corporation
Study Officials
- STUDY DIRECTOR
Pooja Chatterjee
Thoratec Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2005
First Posted
July 21, 2005
Study Start
February 1, 2005
Primary Completion
June 1, 2009
Study Completion
January 1, 2012
Last Updated
June 27, 2022
Results First Posted
October 29, 2013
Record last verified: 2022-06