VentrAssistTM LVAD for the Treatment of Advanced Heart Failure - Destination Therapy
|ClinicalTrials.gov Identifier: NCT00490321|
Recruitment Status : Unknown
Verified September 2009 by Ventracor.
Recruitment status was: Active, not recruiting
First Posted : June 22, 2007
Last Update Posted : September 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|End-stage Heart Failure Cardiomyopathies||Device: VentrAssistTM Left Ventricular Assist Device||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the VentrAssistTM Left Ventricular Assist Device for the Treatment of Advanced Heart Failure - Destination Therapy|
|Study Start Date :||June 2007|
|Estimated Study Completion Date :||June 2012|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00490321
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