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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121472
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : March 19, 2013
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
St. Jude Medical ( Thoratec Corporation )

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Heart Failure, Congestive
Ventricular Dysfunction
Intervention: Device: Thoratec HeartMate II Left Ventricular Assist System (LVAS)

  Participant Flow

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
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] 
[1] Followed for at least 1 year after implantation of HM II LVAS.

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 50.6  (13.0) 
[Units: Participants]
Female   44 
Male   150 
Body Surface Area [1] 
[Units: Sq. meter]
Mean (Standard Deviation)
 1.99  (0.29) 
[1] Body Surface Area (BSA) calculated from patients height and weight
Cardiac Index 
[Units: L/min/m^2]
Mean (Standard Deviation)
 2.0  (0.5) 
PCWP [1] 
[Units: mmHg]
Mean (Standard Deviation)
 26.0  (7.7) 
[1] Pulmonary capillary wedge pressure

  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

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
No text entered.

  More Information

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: St. Jude Medical ( Thoratec Corporation ) Identifier: NCT00121472     History of Changes
Other Study ID Numbers: TC010230-1
First Submitted: July 12, 2005
First Posted: July 21, 2005
Results First Submitted: May 29, 2009
Results First Posted: March 19, 2013
Last Update Posted: May 13, 2016