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

Summary

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.

Eligibility

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.

Conditions2

Locations1 site

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