Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study

Study Success for Primary Endpoint A will be established if the proportion of subjects in the
Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to
that of the Control Group (at two years) according to the pre-specified statistical analysis.

Subject composite success requires the subject to achieve the Effectiveness Endpoint:

1. Two year actuarial survival

2. Freedom from procedures to repair, or replace the implanted device

3. Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up

Study Success for Primary Endpoint B will be established if the proportion of subjects in the
Treatment Group meeting the Subject Success Criteria B is determined to be superior to that
of the Control Group (at three years) according to the pre-specified statistical analysis.

Subject composite success requires the subject to achieve the Effectiveness Endpoint:

1. Three year survival

2. Freedom from the serious adverse event of drive cable or pump pocket infection

Inclusion Criteria:

1. Cardiac transplantation ineligible.

2. Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.

3. Cardiac Index < 2.2 L / min / m2

4. LVEF = 25% or less

5. Patients on Optimal Medical Management (OMM) as defined in Section 9.2 OR dependent on
intra-aortic balloon counter-pulsation for 7 days OR other temporary (indicated for 30
days use, or less) mechanical circulatory support for 7 days, OR supported with IV
inotropes for 7 days and failing to respond.

6. BSA > 1.2 m2 and < 2.5 m2.

Exclusion Criteria:

1. History of cardiac transplantation or left ventricular reduction procedure.

2. Clinical conditions, other than heart failure, which could limit survival to less than
three years.

3. Cause of heart failure due to, or associated with, uncorrected thyroid disease,
obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis,
dermatomyositis, or active myocarditis.

4. Intolerance to anti-coagulation or anti-aggregation therapy required for
post-operative therapy.

5. Known sensitivity to products of bovine origin. The Jarvik 2000 incorporates a
Hemashield vascular graft. Patients with a known sensitivity to products of bovine
origin should not be implanted.

6. Chronic immunosuppression.