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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thoratec Corporation
ClinicalTrials.gov Identifier:
NCT00121485
First received: July 12, 2005
Last updated: November 12, 2013
Last verified: November 2013
Results First Received: November 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Heart Failure, Congestive
Ventricular Dysfunction
Cardiomyopathies
Intervention: Device: Left Ventricular Assist System (LVAS)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
HeartMate II Implantation of HeartMate II LVAS
HeartMate XVE Implantation of HeartMate XVE LVAS

Participant Flow:   Overall Study
    HeartMate II     HeartMate XVE  
STARTED     134     66  
COMPLETED     133     59  
NOT COMPLETED     1     7  
Not implanted                 1                 5  
Crossover                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
HeartMate II Implantation of HeartMate II LVAS
HeartMate XVE Implantation of HeartMate XVE LVAS
Total Total of all reporting groups

Baseline Measures
    HeartMate II     HeartMate XVE     Total  
Number of Participants  
[units: participants]
  134     66     200  
Age  
[units: years]
Mean ± Standard Deviation
  62  ± 12     63  ± 12     62.5  ± 11.6  
Gender  
[units: participants]
     
Female     26     5     31  
Male     108     61     169  
Race/Ethnicity, Customized  
[units: Participants]
     
Asian     2     0     2  
Hispanic     4     0     4  
Black or African American     24     16     40  
White     101     48     149  
Other, unknown     3     2     5  



  Outcome Measures
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1.  Primary:   Composite Endpoint   [ Time Frame: Patients' status at 2 years post-implant ]

2.  Secondary:   Minnesota Living With Heart Failure Questionnaire(MLWHF)   [ Time Frame: Baseline, Months 1,3,6,12 ]

3.  Secondary:   Kansas City Cardiomyopathy Questionnaire (KCCQ)   [ Time Frame: Baseline, Months 1, 3, 6, 12 ]

4.  Secondary:   New York Heart Association (NYHA) Classification   [ Time Frame: Baseline, Months 1, 6, 12 ]

5.  Secondary:   Six Minute Walk Test (6MWT)   [ Time Frame: Baseline, Months 1, 3, 6, 12 ]

6.  Secondary:   Functional Status (Patient Activity Score)   [ Time Frame: Baseline, Months 1, 3, 6, 12 ]

7.  Secondary:   Reoperations   [ Time Frame: Patients were followed until outcome or up to 2 years post-implant, whichever came first ]

8.  Secondary:   Neurocognitive Assessments, Clock Drawing   [ Time Frame: Baseline (1 month), 6 months ]

9.  Secondary:   Neurocognitive Assessments, Wechsler Memory Scale-III (WMS-LM and WMS-LM Delayed)   [ Time Frame: Baseline (1 month), 6 months ]

10.  Secondary:   Neurocognitive Assessments, Wechsler Memory Scale-III Visual Reproduction (WMS-VR and WMS-VR Delayed)   [ Time Frame: Baseline (1 month), 6 months ]

11.  Secondary:   Neurocognitive Assessments, Wechsler Adult Intelligence Test-III, Block Design (WAIS Block)   [ Time Frame: Baseline (1 month), 6 months ]

12.  Secondary:   Neurocognitive Assessments, Boston Naming Test   [ Time Frame: Baseline (1 month), 6 months ]

13.  Secondary:   Wechsler Adult Intelligence Test-III, Digit Symbol (WAIS Digit)   [ Time Frame: Baseline (1 month), 6 months ]

14.  Secondary:   Neurocognitive Assessments, Trail Making A   [ Time Frame: Baseline (1 month), 6 months ]

15.  Secondary:   Neurocognitive Assessments, Trail Making B   [ Time Frame: Baseline (1 month), 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Poornima Sood, MD, MBA, Sr. Director, Clinical Affairs
Organization: Thoratec Corporation
phone: 781 852 8334
e-mail: psood@thoratec.com


Publications of Results:

Responsible Party: Thoratec Corporation
ClinicalTrials.gov Identifier: NCT00121485     History of Changes
Other Study ID Numbers: TC010230-2
Study First Received: July 12, 2005
Results First Received: November 13, 2012
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration