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).
|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|
- Change in stroke incidence at 12 months on the originally implanted HVAD in a new cohort of subjects receiving optimal blood pressure management. [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
- Stroke Free Success [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||October 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.
|Contact: Adelina Paunescuemail@example.com|
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|Principal Investigator:||Francis Pagani, MD||University of Michigan Hospital|
|Principal Investigator:||Joseph Rogers, MD||Duke University|