A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
|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|
|Chronic Heart Failure||Device: HeartWare® VAS Device: Control LVAD|
|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 .
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|