NCT00483197

VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Pivotal Trial

Evaluation of the VentrAssistTM Left Ventricular Assist Device as a Bridge to Cardiac Transplantation - Pivotal Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Ventracor · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of VentrAssistTM LVAD in individuals who are awaiting heart transplants.

Detailed description

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.

Conditions

• End-stage Heart Failure
• Cardiomyopathies

Interventions

Type	Name	Description
DEVICE	VentrAssistTM Left Ventricular Assist Device

Timeline

• Start date: 2007-06-01
• Completion: 2010-06-01
• First posted: 2007-06-06
• Last updated: 2009-09-09

Locations

29 sites across 1 country: United States