Status: Active, not recruiting
Keywords: Heart Failure , LVAD , Artificial Heart , Heart Surgery
IRB Number: 00060024
Specialty: Cardiology, Cardiothoracic Surgery, Cardiothoracic Surgery
Sub Specialties: Heart Failure, Cardiac Mechanical Support, Heart Failure
This study is designed to evaluate the safety and effectiveness of the Jarvik 2000® Left Ventricular Assist System (LVAS) with Post-Auricular Connector (behind the ear driveline), in patients with New York Heart Association Class IIIb and IV end-stage left ventricular failure, who are ineligible for heart transplantation and have demonstrated intolerance to optimal medical therapy for at least 45 of the last 60 days.
The principle purpose of this Study is to determine the percentage of patients in whom Destination Therapy (DT), not candidates for heart transplant, with the Jarvik 2000 LVAS with Post-Auricular Connector permits survival for two years with a Modified Rankin Score of 3 or less at the two-year follow-up, without repair or replacement of the implanted device, and to compare the outcome to a randomized control device.
A second purpose of the Study is to determine if the Jarvik 2000 LVAS with Post-Auricular Connector provides additional protection from serious adverse infection over a three-year follow-up period.
The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for DT at a ratio of 2:1 randomization.