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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
Results First Received: May 29, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Heart Failure, Congestive
Ventricular Dysfunction
Cardiomyopathies
Intervention: Device: Thoratec HeartMate II 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
486 patients were recruited at 36 cardiac transplantation hospitals between 8 Mar 2005 and 21 Apr 2008. After enrolling the initial 133 patients prespecified by the study protocol, an additional 353 patients were enrolled under a Continued Access Protocol(CAP) and in a concurrent Canadian study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
194 patients were followed to at least 1 year after implantation of the device, all 133 of the Pivotal Study Cohort patients and 61 of the US CAP patients, results of which are summarized below and in the final FDA-approved labeling for the HeartMate II LVAS. The remaining 292 patients followed for less than 1 year are not included.

Reporting Groups
  Description
HeartMate II (HMII) HeartMate II Left Ventricular Assist System (HMII LVAS) used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP)).

Participant Flow:   Overall Study
    HeartMate II (HMII)  
STARTED     194  
COMPLETED     194 [1]
NOT COMPLETED     0  
[1] Followed for at least 1 year after implantation of HM II LVAS.



  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.
No text entered.

Reporting Groups
  Description
HM II HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)

Baseline Measures
    HM II  
Number of Participants  
[units: participants]
  194  
Age  
[units: years]
Mean ± Standard Deviation
  50.6  ± 13.0  
Gender  
[units: participants]
 
Female     44  
Male     150  
Body Surface Area [1]
[units: sq.┬ámeter]
Mean ± Standard Deviation
  1.99  ± 0.29  
Cardiac Index  
[units: L/min/m^2]
Mean ± Standard Deviation
  2.0  ± 0.5  
PCWP [2]
[units: mmHg]
Mean ± Standard Deviation
  26.0  ± 7.7  
[1] Body Surface Area (BSA) calculated from patients height and weight
[2] Pulmonary capillary wedge pressure



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Survival   [ Time Frame: 180 days ]

2.  Secondary:   Clinical Reliability (Malfunctions/Failures)   [ Time Frame: continuous ]

3.  Secondary:   Kansas City Cardiomyopathy Questionaire (KCCQ)   [ Time Frame: baseline to 6 months ]

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

5.  Secondary:   Minnesota Living With Heart Failure Questionnaire (MLWHF)   [ Time Frame: Baseline to 6 months ]

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

7.  Secondary:   Reoperations   [ Time Frame: continuous ]

8.  Secondary:   Post-transplant Survival   [ Time Frame: 30 days, 1 year ]


  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:
Publications automatically indexed to this study:

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