Feasibility Study of the Intravascular Ventricular Assist System (iVAS)
Purpose
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
Conditions
- Heart Failure NYHA Class III
- Heart Failure NYHA Class IV
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Single Arm |
All patients are treated with the intravascular ventricular assist system (iVAS). |
|
Recruiting Locations
More Details
- Status
- Unknown status
- Sponsor
- NuPulseCV
Detailed 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.