VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
Recruitment status was Active, not recruiting
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|
Currently, patients with Stage D heart failure who are not transplant candidates are treated with a spectrum of therapies, including specialized medical management as well as mechanical support with an LVAD approved by FDA for destination therapy. However, there is substantial variation in the therapeutic approaches employed to treat these patients, with relatively low numbers of patients receiving DT LVAD therapy to date. Therefore, the VentrAssist DT trial is designed to provide maximal flexibility to the investigators/clinicians to incorporate their clinical judgment in managing these complex patients.
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