Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

This is a single-arm, non-randomized study designed to assess the preliminary safety and
clinical performance of the NuPulseCV iVAS.

Data obtained from the study will be used to make device modifications, refine the patient
population, and inform the design a future clinical trial suitable for assessing longer-term
use in heart failure patients.

Main Inclusion Criteria:

1. At least 18 years of age.

2. If female, are postmenopausal or surgically sterilized, or have a negative pregnancy
test 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 or
equivalents; 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.