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

June 23, 2022 updated by: Abbott Medical Devices

The HeartMate II LVAS Pivotal Study Protocol, Destination Therapy

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • HeartMate II
  • Thoratec
  • 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:
  • HeartMate II
  • Thoratec
  • ventricular assist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Endpoint
Time Frame: Patients' status at 2 years post-implant
Survival at two (2) years free of stroke, or reoperation to repair or replace the device
Patients' status at 2 years post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minnesota Living With Heart Failure Questionnaire(MLWHF)
Time Frame: Baseline, Months 1,3,6,12
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.
Baseline, Months 1,3,6,12
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: Baseline, Months 1, 3, 6, 12
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.
Baseline, Months 1, 3, 6, 12
New York Heart Association (NYHA) Classification
Time Frame: Baseline, Months 1, 6, 12
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
Baseline, Months 1, 6, 12
Six Minute Walk Test (6MWT)
Time Frame: Baseline, Months 1, 3, 6, 12
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.
Baseline, Months 1, 3, 6, 12
Functional Status (Patient Activity Score)
Time Frame: Baseline, Months 1, 3, 6, 12
Metabolic Equivalent Score (METs). Ranges: Very Low, Low, Moderate, High, Very High
Baseline, Months 1, 3, 6, 12
Reoperations
Time Frame: Patients were followed until outcome or up to 2 years post-implant, whichever came first
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
Patients were followed until outcome or up to 2 years post-implant, whichever came first
Neurocognitive Assessments, Clock Drawing
Time Frame: Baseline (1 month), 6 months
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.
Baseline (1 month), 6 months
Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)
Time Frame: Baseline (1 month), 6 months
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
Baseline (1 month), 6 months
Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)
Time Frame: Baseline (1 month), 6 months
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.
Baseline (1 month), 6 months
Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)
Time Frame: Baseline (1 month), 6 months
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.
Baseline (1 month), 6 months
Neurocognitive Assessments, Boston Naming Test
Time Frame: Baseline (1 month), 6 months
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.
Baseline (1 month), 6 months
Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)
Time Frame: Baseline (1 month), 6 months
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.
Baseline (1 month), 6 months
Neurocognitive Assessments, Trail Making A
Time Frame: Baseline (1 month), 6 months
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.
Baseline (1 month), 6 months
Neurocognitive Assessments, Trail Making B
Time Frame: Baseline (1 month), 6 months
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.
Baseline (1 month), 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Thoratec Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 12, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TC010230-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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