Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT00121472
First received: July 12, 2005
Last updated: March 18, 2013
Last verified: March 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 a bridge to cardiac transplantation in end-stage heart failure patients who are listed for cardiac transplant but are at imminent risk of dying.

The HeartMate II LVAS was approved by the US FDA on April 21, 2008, as a bridge to cardiac transplantation (reference PMA P060040). It was approved for commercial distribution in Canada on May 20, 2009 (reference Medical Device Licence #79765). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The HeartMate II LVAS Pivotal Study Protocol, Bridge to Cardiac Transplantation

Resource links provided by NLM:


Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:
  • Survival [ Time Frame: 180 days ] [ Designated as safety issue: No ]
    Survival to cardiac transplantation or 180 days on left ventricular assist system (LVAS) support while remaining listed for cardiac transplantation as United Network for Organ Sharing (UNOS)status 1A or 1B (please refer to www.unos.org for complete definitions of status).


Secondary Outcome Measures:
  • Clinical Reliability (Malfunctions/Failures) [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
    Confirmed malfunctions/Serious Adverse Events

  • Kansas City Cardiomyopathy Questionaire (KCCQ) [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
    KCCQ is a validated instrument to self assess quality of life including physical function and social function. The instrument provides two scores, the Overall Summary (OSS) and Clinical Summary (CSS). 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 six months were compared to their baseline scores and the resulting positive scores indicated improved quality of life.

  • New York Heart Association (NYHA) Classification [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ 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

  • Minnesota Living With Heart Failure Questionnaire (MLWHF) [ Time Frame: Baseline to 6 months ] [ 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' score at six months was compared to their baseline score and the resulting negative score indicates improved quality of life.

  • Six Minute Walk Test (6MWT) [ Time Frame: baseline to 6 months ] [ 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.

  • Reoperations [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
    Additional surgery after the initial implant operation

  • Post-transplant Survival [ Time Frame: 30 days, 1 year ] [ Designated as safety issue: No ]
    30 day and 1 year post transplant survival


Enrollment: 194
Study Start Date: March 2005
Study Completion Date: May 2010
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Thoratec HeartMate II Left Ventricular Assist System (LVAS)
    Implantation of ventricular assist device to provide 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. Patient outcomes will be compared to objective performance criteria based on historical data from other Thoratec implantable ventricular assist devices.

  Eligibility

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:

  • Listed for cardiac transplantation
  • NYHA Class IV heart failure symptoms
  • On inotropic support, if tolerated
  • Despite medical therapy, the patient must meet hemodynamic criteria for cardiogenic shock

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: NCT00121472

  Show 36 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: NCT00121472     History of Changes
Other Study ID Numbers: TC010230-1
Study First Received: July 12, 2005
Results First Received: May 29, 2009
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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 22, 2014