Emerging LVAD Technology for the Use - Washington Hospital Center
Emerging LVAD Technology for the Use - Washington Hospital Center
Emerging LVAD Technology for the Use - Washington Hospital Center
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HeartWare Ventricular Assist System<br />
International Trial<br />
• Enrolled: 50 patients at 5 <strong>Center</strong>s<br />
• Completed: June 2008<br />
• CE Mark and TGA approval<br />
ADVANCE FDA Bridge to Transplant Trial<br />
• Enrolled: 140 patients at 30 centers<br />
• PMA: filed December 2010<br />
• CAP (Continued Access Protocol): enrolled 202 additional patients<br />
ENDURANCE FDA Destination Therapy Trial<br />
• Enrolled: 430+ patients (target 450)<br />
• Target Enrollment Completion: 2Q12<br />
REVIVE-IT Trial<br />
• NHLBI sponsored trial of HVAD Pump in Class III patients<br />
• Enrollment target: 100 patients in ten centers<br />
• Anticipate enrollment beginning 2012
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