A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) (DT2)
|ClinicalTrials.gov Identifier: NCT01966458|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2013
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
|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|
|Estimated 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966458
Show 47 Study Locations
|Principal Investigator:||Francis Pagani, MD||University of Michigan Hospital|
|Principal Investigator:||Joseph Rogers, MD||Duke University|