VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
The purpose of this study is to evaluate the safety and effectiveness of LVADs in providing long-term circulatory support for patients who have chronic stage D heart failure and are ineligible for a heart transplant.
This is a multi-center, prospective, randomized, controlled clinical trial, which is comprised of two independent modules.
End-stage Heart Failure
Device: VentrAssistTM Left Ventricular Assist Device
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy|
- Module A: Survival without a disabling stroke.
- Module B: A composite endpoint of disabling stroke-free survival without device replacement or repair due to failure of the device to provide adequate circulatory support.
- •Safety •Functional Status and Hospitalizations •Quality of Life and Neurocognitive Assessment
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||June 2012|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490321
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