VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial
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|ClinicalTrials.gov Identifier: NCT00483197|
Recruitment Status : Unknown
Verified September 2009 by Ventracor.
Recruitment status was: Active, not recruiting
First Posted : June 6, 2007
Last Update Posted : September 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|End-stage Heart Failure Cardiomyopathies||Device: VentrAssistTM Left Ventricular Assist Device||Phase 3|
LVADs are efficacious in improving survival and functional status when used as a bridge to transplantation. The purpose of this study is to evaluate the safety and effectiveness of the VentrAssist LVAD in providing circulatory support in individuals who are awaiting heart transplants.
The VentrAssist LVAD is a centrifugal flow pump. Its small size and mechanical simplicity offers benefits not available with currently approved LVADs, including facilitating a more limited implantation procedure, which could reduce surgical morbidity and mortality.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial|
|Study Start Date :||June 2007|
|Estimated Study Completion Date :||June 2010|
- Survival to cardiac transplantation or to 180 days post implantation and listed for cardiac transplantation in categories UNOS 1A or 1B.
- Quality of life
- Functional status
- Neurocognitive function
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483197
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