A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare® HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy). Subjects will be randomized to HeartWare® HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare® HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 5 years post implant.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: Yes ]
- Stroke-free success [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]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 .
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01966458
Show 49 Study Locations
|Principal Investigator:||Francis Pagani, MD||University of Michigan Hospital|
|Principal Investigator:||Joseph Rogers, MD||Duke University|