A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) (DT2)
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|ClinicalTrials.gov Identifier: NCT01966458|
Recruitment Status : Completed
First Posted : October 21, 2013
Results First Posted : April 23, 2018
Last Update Posted : October 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Device: HeartWare® VAS (HVAD) Device: Control LVAD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||494 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2020|
Experimental: HeartWare® VAS (HVAD)
Implant of HeartWare® Ventricular Assist System
Device: HeartWare® VAS (HVAD)
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.
Active Comparator: Control LVAD
Implant of FDA-approved LVAD approved for destination therapy
Device: Control LVAD
Any FDA-approved LVAD for destination therapy.
- Number of Participants With Neurologic Injury [ Time Frame: Implant to 12 Months ]The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) > 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability.
- Number of HeartWare VAS Participants With Stroke/TIA [ Time Frame: Implant to 12 Months ]The first secondary endpoint is the number of HeartWare VAS participants with stroke/TIA at 12 months on the originally implanted device.
- Number of Participants With Stroke-Free Success [ Time Frame: Implant to 12 Months ]Success is defined as alive on the originally implanted device, electively transplanted or explanted due to subject recovery and free from disabling stroke (Modified Rankin Scale >=4).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966458
|Principal Investigator:||Francis Pagani, MD||University of Michigan Hospital|
|Principal Investigator:||Joseph Rogers, MD||Duke University|