Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

Main Inclusion Criteria:

1. At least 18 years of age.

2. If female, are postmenopausal or surgically sterilized, or have a negative pregnancytest within seven (7) days of invasive testing.

3. Advanced heart failure (NYHA Class III or IV)

Main Exclusion Criteria:

1. Hypotension treated with the following medications: epinephrine, norepinephrine,vasopressin, methylene blue, phenylephrine, or angiotensin II.

2. Receiving more than two inotropes.

3. Subclavian stenosis or stent.

4. Currently receiving circulatory support including ECMO, Impella, TandemLife orequivalents; or any durable VAD.

5. Atrial fibrillation without ventricular pacing.

6. Concomitant, non-cardiac disease process with life expectancy < 1 year.

7. Significant abnormalities of the aorta, such as aneurysms, coarctation of the aorta,or an extremely tortuous aorta.

8. Severe end-organ dysfunction or failure.

9. Any other condition the heart team believes inappropriate for this study.