Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Thoratec Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT00121472
First received: July 12, 2005
Last updated: April 25, 2008
Last verified: April 2008
History of Changes
  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). Patients enrolled into the clinical trial will continue to be followed until all have reached a clinical outcome. Canadian study sites continue enrollment pending review and approval of Canada Medical Device License application.


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

Thoratec Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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:

U.S. FDA Resources

Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:
  • Survival to cardiac transplantation or 180 days on LVAS support while remaining listed as status 1A or 1B. [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Clinical reliability (malfunctions/failures) [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: baseline, 1 month, 3 months, 6 months ] [ Designated as safety issue: No ]
  • Reoperations [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
  • Neurocognitive assessments [ Time Frame: 1 month, 3 months, 6 months ] [ Designated as safety issue: Yes ]
  • Post-transplant survival [ Time Frame: 30 days, 1 year ] [ Designated as safety issue: No ]

Enrollment: 484
Study Start Date: February 2005
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: October 2008 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121472

  Show 36 Study Locations
Sponsors and Collaborators
Thoratec Corporation
Investigators
Study Director: Laura Damme Thoratec Corporation
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laura Damme, Sr. Director, Clinical Affairs, Thoratec Corporation
ClinicalTrials.gov Identifier: NCT00121472     History of Changes
Other Study ID Numbers: TC010230-1
Study First Received: July 12, 2005
Last Updated: April 25, 2008
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
Ventricular Dysfunction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2012