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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Thoratec Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT00121485
First received: July 12, 2005
Last updated: January 21, 2010
Last verified: January 2010
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 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)

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: 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:

U.S. FDA Resources

Further study details as provided by Thoratec Corporation:

Primary Outcome Measures:
  • Survival to two (2) years free of: stroke, or reoperation to repair or replace the device [ Time Frame: continuous ] [ Designated as safety issue: Yes ]

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 ]

Estimated Enrollment: 260
Study Start Date: February 2005
Estimated Study Completion Date: June 2011
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00121485

  Show 47 Study Locations
Sponsors and Collaborators
Thoratec Corporation
Investigators
Study Director: Laura Damme Thoratec Corporation
  More Information

No publications provided by Thoratec Corporation

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: NCT00121485     History of Changes
Other Study ID Numbers: TC010230-2
Study First Received: July 12, 2005
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

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 May 21, 2013