Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS

Specific Aims The aims of this trial are to evaluate the safety and effectiveness of the
DuraHeart™ LVAS in patients with advanced heart failure who require LVAS support as a bridge
to cardiac transplantation.

Study Population The patient population for this trial consists of patients with end stage
heart failure awaiting cardiac transplantation. Patients must be listed for transplant with
UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in
the study regardless of gender, race or ethnicity.

Study Design This is a multi-center, prospective, single arm study in which the lower
one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur
within an 18-month time period at up to 40 centers. All patients will be followed for all
endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or
death, whichever occurs first. For those patients who remain on support after 180 days,
survival and device reliability data will continue to be collected on a regular basis. If
patients are transplanted, survival at day 30 post cardiac transplantation will also be
assessed.