Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Conditions
Keywords
Heart failure, Bridge-to-transplant, circulatory support, VAD, IABP
Brief summary
The purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (iVAS).
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.
Interventions
DEVICEintravascular ventricular assist system (iVAS)
A mechanical circulatory support device using the principles of counterpulsation.
Sponsors
NuPulseCV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival to transplant or stroke-free survival | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients demonstrating improvement in Seattle Heart Failure Model Score | 30 days |
| Number of patients who deteriorate requiring escalation of treatment | 30 days |
| Rate of occurrence of all adverse events | 30 days |
| Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST) | 30 days |
| Rate of occurrence of serious device-related adverse events | 30 days |
| Number of patients demonstrating improvement in NYHA Classification | 30 days |
| Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL) | 30 days |
| Rate of occurrence of procedure-related adverse events | 30 days |
Countries
United States
Contacts
Primary ContactLori Rhoten
Outcome results
None listed