Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT00121485
First received: July 12, 2005
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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).


Condition Intervention
Heart Failure, Congestive
Ventricular Dysfunction
Cardiomyopathies
Device: Left Ventricular Assist System (LVAS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy

Resource links provided by NLM:


Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:
  • Composite Endpoint [ Time Frame: Patients' status at 2 years post-implant ] [ Designated as safety issue: Yes ]
    Survival at two (2) years free of stroke, or reoperation to repair or replace the device


Secondary Outcome Measures:
  • Minnesota Living With Heart Failure Questionnaire(MLWHF) [ Time Frame: Baseline, Months 1,3,6,12 ] [ Designated as safety issue: No ]
    MLWHF is a validated instrument to self assess how heart failure and its treatment affect the key physical, emotional, social and psychological dimensions of quality of life. The instrument is made up of 21 items that assess the patient's perception of these dimensions on a scale ranging from no (0) to very much (5). The total MLWHF score is calculated by adding the scores for all 21 items (range, 0-105). A lower score indicates a better quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months post-implant are presented and indicate improved quality of life.

  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline, Months 1, 3, 6, 12 ] [ Designated as safety issue: No ]
    KCCQ is a validated instrument to self assess quality of life including physical function and social function. Scores are calculated based on responses to the questionnaire, on a scale from 0-100. The higher the score, the better the quality of life. The patients' scores at Baseline, 1, 3, 6 and 12 Months are presented and indicate improved quality of life.

  • New York Heart Association (NYHA) Classification [ Time Frame: Baseline, Months 1, 6, 12 ] [ Designated as safety issue: No ]
    NYHA relates symptoms to every day activities and patients quality of life. Class 1 = no limitations on physical activity Class 2 - slight limitation of physical activity Class 3 - marked limitation of physical activity Class 4 = unable to carry out any physical activity without discomfort

  • Six Minute Walk Test (6MWT) [ Time Frame: Baseline, Months 1, 3, 6, 12 ] [ Designated as safety issue: No ]
    The Six Minute Walk Test(6MWT) measures the distance that a patient can walk in a period of 6 minutes. The distance walked is measured in meters. This test measures the patients' functional status. The more meters a patient can walk over baseline indicates improvement in functional status.

  • Functional Status (Patient Activity Score) [ Time Frame: Baseline, Months 1, 3, 6, 12 ] [ Designated as safety issue: No ]
    Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High

  • Reoperations [ Time Frame: Patients were followed until outcome or up to 2 years post-implant, whichever came first ] [ Designated as safety issue: Yes ]
    The number of additional surgeries after the initial pump implant. Data is presented as the percentage of patients who required a reoperation for pump replacement or repair, bleeding or other reasons

  • Neurocognitive Assessments, Clock Drawing [ Time Frame: Baseline (1 month), 6 months ] [ Designated as safety issue: No ]
    Clock drawing is a measure of visual-spatial integrity, visual motor skills and organizational ability. The drawing was administered with the command version with no time restraint. The clock is scored from 1-10, with 10 a better score.

  • Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed) [ Time Frame: Baseline (1 month), 6 months ] [ Designated as safety issue: No ]
    The WMS-LM is a measure of auditory attention and memory. This contextual memory task requires patients to recall a passage read by the examiner. Their memory tasks are avoided during the intervening time so as not to disrupt recall. The WMS-LM test provides a comparision for immediate recall and the WMS-LM Delayed provides a comparison for recall that is delayed 30 minutes. The test is scored in a range from 0-50, where the higher score is considered better

  • Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed) [ Time Frame: Baseline (1 month), 6 months ] [ Designated as safety issue: No ]
    The WMS-VR is a measure of visual memory. This is a graphic memory task requiring both immediate recall and after a 30 minute delay (WMS-VR Delayed). The scoring range is 0-104 where the higher score is better.

  • Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block) [ Time Frame: Baseline (1 month), 6 months ] [ Designated as safety issue: No ]
    The WAIS block is a measure of visual spatial and visual motor ability. The patient is given a stimulus configuration to replicate with red and white blocks while being timed, first starting with four blocks and progressing to a nine block configuration. Performance is scored on time upon full completion of the task with a maximum of 68 points. The higher the score, the better.

  • Neurocognitive Assessments, Boston Naming Test [ Time Frame: Baseline (1 month), 6 months ] [ Designated as safety issue: No ]
    Fifteen pictures of objects are presented to the patient. The patient is asked to name the object without prompting. A Correct identification represents one point. This test is designed to test language. Scores are from 0-15, higher being better.

  • Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit) [ Time Frame: Baseline (1 month), 6 months ] [ Designated as safety issue: No ]
    The WAIS Digit is a measure of visual motor speed and abstracting ability. The patient is given the numbers one to nine with an associated symbol. Performance is scored on time with correct amount completed with a maximum of 133 points, where higher is better.

  • Neurocognitive Assessments, Trail Making A [ Time Frame: Baseline (1 month), 6 months ] [ Designated as safety issue: No ]
    This is a visual motor task measuring processing speed. The patient is required to draw a line between sequential numbers while being timed to completion. The score is time to completion in seconds and lower score is better.

  • Neurocognitive Assessments, Trail Making B [ Time Frame: Baseline (1 month), 6 months ] [ Designated as safety issue: No ]
    This is a visual motor task measuring processing speed and executive functions. The patient is required to draw a line between alternating sequential numbers and letters while being timed to completion. Testing scores are time to completion in seconds with lower score being better.


Enrollment: 200
Study Start Date: February 2005
Study Completion Date: January 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HeartMate II
Implantation of HeartMate II LVAS
Device: Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
Other Names:
  • Thoratec
  • HeartMate II
  • ventricular assist
Active Comparator: HeartMate XVE
Implantation of HeartMate XVE LVAS
Device: Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
Other Names:
  • Thoratec
  • HeartMate II
  • ventricular assist

Detailed Description:

The HeartMate II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via a rigid inlet cannula and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastomosis. Power and control of the pump are delivered through a percutaneous cable from the pump to the belt-worn System Driver.

The Destination Therapy trial is a prospective, randomized, unblinded, non-inferiority evaluation of the HeartMate II LVAS, compared to the HeartMate XVE.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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%

Exclusion Criteria:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121485

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
Sharp Memorial Hospital
San Diego, California, United States, 92123
California Pacific Medical Center
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Hospital
Denver, Colorado, United States, 80262
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Shands Hospital @ University of Florida
Gainesville, Florida, United States, 32610
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
United States, Indiana
Methodist Hospital
Indianapolis, Indiana, United States, 46206
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Tufts / New England Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes-Jewish Hospital/Washington University
St. Louis, Missouri, United States, 63110
United States, Nebraska
Bryan LGH Heart Institute
Lincoln, Nebraska, United States, 68516
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
New York Columbia Presbyterian Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43212
United States, Oklahoma
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Milton Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Hospital of University of PA
Philadelphia, Pennsylvania, United States, 19104
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Tennessee
Baptist Memorial Hospital
Memphis, Tennessee, United States, 38120
United States, Texas
Medical City Hospital Dallas
Dallas, Texas, United States, 75230
Texas Heart Institute
Houston, Texas, United States, 77030
United States, Utah
LDS Hospital (Intermountain Health Care)
Salt Lake City, Utah, United States, 84143
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23510
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, Wisconsin
University of Wisconsin Medical School
Madison, Wisconsin, United States, 53792
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Hospital Royal Victoria / McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Thoratec Corporation
Investigators
Study Director: Poornima Sood, MD, MBA Thoratec Corporation
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT00121485     History of Changes
Other Study ID Numbers: TC010230-2
Study First Received: July 12, 2005
Results First Received: November 13, 2012
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Thoratec Corporation:
Heart-assist devices

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014