Overview
This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. 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 Destination Therapy.
Description
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:
- Two year actuarial survival
- Freedom from procedures to repair, or replace the implanted device
- 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:
- Three year survival
- Freedom from the serious adverse event of drive cable or pump pocket infection
Eligibility
Inclusion Criteria:
- Cardiac transplantation ineligible.
- Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
- Cardiac Index < 2.2 L / min / m2
- LVEF = 25% or less
- 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.
- BSA > 1.2 m2 and < 2.5 m2.
Exclusion Criteria:
- History of cardiac transplantation or left ventricular reduction procedure.
- Clinical conditions, other than heart failure, which could limit survival to less than three years.
- Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
- Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
- 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.
- Chronic immunosuppression.