HeartMate II is two studies with one device. One study is for patients who are awaiting a heart transplant. The other study is for patients who are not eligible for a heart transplant. The purpose of this study is to see if the HeartMate II Left Ventricular Assist System (LVAS)* can assist a failing heart. The HeartMate II is an experimental device that is being tested for its safety and pumping ability.
You MAY be eligible for this study if:
You have been listed with UNOS* 1A or 1B
You have been diagnosed with New York Heart Association Class IV heart failure
You MAY NOT be eligible for this study if:
You have an intolerance to anticoagulant* or antiplatelet* therapies or any other pre/post operation therapy (the Investigator will require based upon the patient's health status)
You have heart failure due to, or associated with, uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
