Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
Status unconfirmed · Not applicable
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT01627821
- Run by
- Jarvik Heart, Inc.
- People needed
- 350
- Starts
- 2013-02-01
- Expected to finish
- 2025-03-01
- Last updated by the study team
- 2024-03-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Columbia/NY Presbyterian — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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