A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
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|ClinicalTrials.gov Identifier: NCT01966458|
Recruitment Status : Unknown
Verified September 2015 by HeartWare, Inc..
Recruitment status was: Active, not recruiting
First Posted : October 21, 2013
Last Update Posted : September 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure||Device: HeartWare® VAS Device: Control LVAD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||465 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|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||August 2016|
Experimental: HeartWare® VAS
Implant of HeartWare® Ventricular Assist System
Device: 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.
Active Comparator: Control LVAD
Implant of FDA-approved LVAD approved for destination therapy
Device: Control LVAD
Any FDA-approved LVAD for destination therapy.
- The primary endpoint is the incidence at 12 months on the originally implanted device of neurologic injury, defined as an ICVA or HCVA with MRS > 0 at 24-weeks post-stroke, or a TIA, or a spinal cord infarction. [ Time Frame: 12 month ]
- Stroke-free success [ Time Frame: 12 month ]There are two secondary endpoints: 1. first secondary endpoint is the reduction in stroke/TIA incidence at 12 months on the originally implanted HVAD compared to 17.7% (the lower bound of a pre-defined margin of superiority) in a new cohort of subjects receiving optimal blood pressure management; 2. the second secondary endpoint is a non-inferiority test comparing HVAD to control LVAD considering stroke-free success (Modified Rankin Score <4 at 24-weeks post-stroke) at 12 months .
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
Show 49 Study Locations
|Principal Investigator:||Francis Pagani, MD||University of Michigan Hospital|
|Principal Investigator:||Joseph Rogers, MD||Duke University|