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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

July 12, 2005
January 21, 2010
February 2005
June 2009   (final data collection date for primary outcome measure)
Survival to two (2) years free of: stroke, or reoperation to repair or replace the device [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
Survival to two (2) years free of: stroke, or reoperation to repair or replace the device
Complete list of historical versions of study NCT00121485 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of adverse events
  • Clinical reliability (malfunctions/failures)
  • Quality of Life
  • Functional status
  • Reoperations
  • Neurocognitive assessments
  • Post-transplant survival at 30 days and 1 year
Not Provided
Not Provided
 
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
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).

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Failure, Congestive
  • Ventricular Dysfunction
  • Cardiomyopathies
Device: Left Ventricular Assist System (LVAS)
Implantation of left ventricular assist device for hemodynamic support
Other Names:
  • Thoratec
  • HeartMate II
  • ventricular assist
  • Experimental: HeartMate II
    Implantation of HeartMate II LVAS
    Intervention: Device: Left Ventricular Assist System (LVAS)
  • Active Comparator: HeartMate XVE
    Implantation of HeartMate XVE LVAS
    Intervention: Device: Left Ventricular Assist System (LVAS)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
June 2011
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00121485
TC010230-2
Yes
Laura Damme, Sr. Director, Clinical Affairs, Thoratec Corporation
Thoratec Corporation
Not Provided
Study Director: Laura Damme Thoratec Corporation
Thoratec Corporation
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP