Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

Main Inclusion Criteria:

At least 18 years of age.
If female, are postmenopausal or surgically sterilized, or have a negative pregnancy test within seven (7) days of invasive testing.
Advanced heart failure (NYHA Class III or IV)

Main Exclusion Criteria:

Hypotension treated with the following medications: epinephrine, norepinephrine, vasopressin, methylene blue, phenylephrine, or angiotensin II.
Receiving more than two inotropes.
Subclavian stenosis or stent.
Currently receiving circulatory support including ECMO, Impella, TandemLife or equivalents; or any durable VAD.
Atrial fibrillation without ventricular pacing.
Concomitant, non-cardiac disease process with life expectancy < 1 year.
Significant abnormalities of the aorta, such as aneurysms, coarctation of the aorta, or an extremely tortuous aorta.
Severe end-organ dysfunction or failure.
Any other condition the heart team believes inappropriate for this study.