Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

NuPulseCV

Status: Unknown

Conditions: Heart Failure NYHA Class IV; Heart Failure NYHA Class III

Treatments: Device: intravascular ventricular assist system (iVAS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02645539

PRO-10001

Details and patient eligibility

About

The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Single Arm

Experimental group

Description:

All patients are treated with the intravascular ventricular assist system (iVAS).

Treatment:

Device: intravascular ventricular assist system (iVAS)