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A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) (DT2)

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ClinicalTrials.gov Identifier: NCT01966458
Recruitment Status : Active, not recruiting
First Posted : October 21, 2013
Results First Posted : April 23, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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 (HVAD)
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
Subjects were considered enrolled upon signing informed consent. 19 enrolled subjects weren't randomized as they were considered screen failures. 10 subjects were randomized but didn't receive a device due to death (with 1 subject dying post anesthesia but prior to Left Ventricular Assist Device (LVAD) implant) or screen failure prior to implant.

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   308   157 
COMPLETED   304   155 
NOT COMPLETED   4   2 



  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
  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]
 308   157   465 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.3  (11.44)   64.2  (11.14)   63.6  (11.34) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      56  18.2%      32  20.4%      88  18.9% 
Male      252  81.8%      125  79.6%      377  81.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      20   6.5%      3   1.9%      23   4.9% 
Not Hispanic or Latino      288  93.5%      154  98.1%      442  95.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
American Indian/Alaska Native      2   0.6%      1   0.6%      3   0.6% 
Asian      1   0.3%      2   1.3%      3   0.6% 
Black/African American      72  23.4%      33  21.0%      105  22.6% 
Native Hawaiian/Pacific Islander      1   0.3%      0   0.0%      1   0.2% 
White      221  71.8%      118  75.2%      339  72.9% 
Other      11   3.6%      3   1.9%      14   3.0% 


  Outcome Measures

1.  Primary:   Number of Participants With Neurologic Injury   [ Time Frame: Implant to 12 Months ]

2.  Secondary:   Number of HeartWare VAS Participants With Stroke/TIA   [ Time Frame: Implant to 12 Months ]

3.  Secondary:   Number of Participants With Stroke-Free Success   [ Time Frame: Implant to 12 Months ]


  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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01966458     History of Changes
Other Study ID Numbers: HW004-A
First Submitted: October 17, 2013
First Posted: October 21, 2013
Results First Submitted: February 12, 2018
Results First Posted: April 23, 2018
Last Update Posted: May 30, 2018