You are being asked to participate because your
physician has determined that you have advanced heart failure and require
additional circulatory support. Your heart failure has progressed and the
damage to your heart is preventing it from sufficiently pumping blood to the
rest of your body. Your physician has determined that guideline directed
medical therapy for your advanced heart failure is not working and that you may
benefit from additional mechanical circulatory support with an intra-aortic balloon
pump (IABP, which is implanted through a major artery in your body) or with a
ventricular assist device (VAD, which is implanted via open heart surgery). IABPs
and VADs are the most common devices used to help patients feel better and live
longer. The IABP is a sausage shaped balloon that is inserted into your artery
and sits in the chest portion of the aorta.
It inflates while the heart relaxes. It acts like an extra heart pump. This
helps with circulating blood in your body. The iVAS also has a skin interface
device facilitating patient ambulation, which allows for increased mobility.
This study will evaluate a device called the NuPulseCV intravascular
ventricular assist system (iVAS) that is similar to an IABP.
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