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The HeartWare™ Ventricular Assist System as Destination Therapy of Advanced Heart Failure: the ENDURANCE Trial (ENDURANCE)

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ClinicalTrials.gov Identifier: NCT01166347
Recruitment Status : Completed
First Posted : July 21, 2010
Results First Posted : February 28, 2018
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
HeartWare, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Heart Failure
Interventions: Device: HeartWare® VAS
Device: Control LVAD

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five enrolled subjects were not randomized to a group due to lack of written insurance approval to receive the study device, death prior to randomization, prior screen failure (later improved), or withdrawal of consent.

Reporting Groups
  Description
HeartWare® Ventricular Assist System (VAS) HeartWare® Ventricular Assist System(VAS): The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
Control Left Ventricular Assist Device (LVAD) Control Left Ventricular Assist Device (LVAD): Any Food and Drug Administration (FDA)-approved LVAD for destination therapy.

Participant Flow:   Overall Study
    HeartWare® Ventricular Assist System (VAS)   Control Left Ventricular Assist Device (LVAD)
STARTED   297   149 
COMPLETED   295   148 
NOT COMPLETED   2   1 



  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.
Only randomized subjects who successfully received an implant are included.

Reporting Groups
  Description
HeartWare® VAS HeartWare® VAS: The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
Control LVAD Control LVAD: Any FDA-approved LVAD for destination therapy.
Total Total of all reporting groups

Baseline Measures
   HeartWare® VAS   Control LVAD   Total 
Overall Participants Analyzed 
[Units: Participants]
 297   148   445 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.9  (11.60)   66.2  (10.23)   64.7  (11.20) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      70  23.6%      26  17.6%      96  21.6% 
Male      227  76.4%      122  82.4%      349  78.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      9   3.0%      6   4.1%      15   3.4% 
Not Hispanic or Latino      288  97.0%      142  95.9%      430  96.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native   0   0   0 
Asian   2   1   3 
Black or African American   66   32   98 
Native Hawaiian or Other Pacific Islander   0   0   0 
White   228   115   343 
Other   1   0   1 


  Outcome Measures

1.  Primary:   Stroke-Free Survival Probability for 2 Years Post Implant   [ Time Frame: Implant to 2 years ]

2.  Secondary:   Number of Participants With Bleeding   [ Time Frame: Implant to two years ]

3.  Secondary:   Number of Participants With Major Infections   [ Time Frame: Implant to two years ]

4.  Secondary:   Overall Survival at 2 Years   [ Time Frame: Implant to two years ]

5.  Secondary:   Number of Participants With Device Malfunctions   [ Time Frame: Implant to two years ]

6.  Secondary:   Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)   [ Time Frame: Change from baseline to 2 years ]

7.  Secondary:   Health Status Change Measured by EuroQol EQ-5D (Version 3L)   [ Time Frame: Change from baseline to 2 years ]

8.  Secondary:   Change in Functional Status Measured by New York Heart Association (NYHA) Class   [ Time Frame: Change from baseline to 2 years ]

9.  Secondary:   Change in Functional Status as Measured by 6-minute Walk   [ Time Frame: Change from baseline to 2 years ]

10.  Secondary:   Length of Initial Hospitalization   [ Time Frame: Implant to the end of the initial hospitalization ]

11.  Secondary:   Number of Participants Who Had a Re-hospitalization   [ Time Frame: Implant to two years ]

12.  Secondary:   Duration of Re-hospitalization   [ Time Frame: Implant to two years ]

13.  Secondary:   Cause of Re-hospitalization   [ Time Frame: Implant to two years ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Thomas Vassiliades
Organization: Medtronic
phone: +15085321942
e-mail: thomas.a.vassiliades@medtronic.com


Publications of Results:

Responsible Party: HeartWare, Inc.
ClinicalTrials.gov Identifier: NCT01166347     History of Changes
Other Study ID Numbers: HW004 ENDURANCE
First Submitted: July 16, 2010
First Posted: July 21, 2010
Results First Submitted: December 19, 2017
Results First Posted: February 28, 2018
Last Update Posted: February 28, 2018