Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

  Show 47 Study Locations
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:
Cardiomyopathies
Heart Failure
Ventricular Dysfunction
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014