Feasibility Study of the Intravascular Ventricular Assist System (iVAS)

Study Overview
=================
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.

Official Title
-----------------
A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study

Conditions
-----------------
Heart Failure NYHA Class III, Heart Failure NYHA Class IV

Intervention / Treatment
-----------------
* Device: intravascular ventricular assist system (iVAS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: At least 18 years of age. If female, are postmenopausal or surgically sterilized, or have a negative pregnancy test within seven (7) days of invasive testing. 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. Receiving more than two inotropes. Subclavian stenosis or stent. Currently receiving circulatory support including ECMO, Impella, TandemLife or equivalents; or any durable VAD. Atrial fibrillation without ventricular pacing. Concomitant, non-cardiac disease process with life expectancy < 1 year. Significant abnormalities of the aorta, such as aneurysms, coarctation of the aorta, or an extremely tortuous aorta. Severe end-organ dysfunction or failure. Any other condition the heart team believes inappropriate for this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>All patients are treated with the intravascular ventricular assist system (iVAS). | Device: intravascular ventricular assist system (iVAS)<br>* A mechanical circulatory support device using the principles of counterpulsation.<br>* Other names: NuPulse;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to transplant or stroke-free survival |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who deteriorate requiring escalation of treatment |  | 30 days | 
| Rate of occurrence of all adverse events |  | 30 days | 
| Rate of occurrence of procedure-related adverse events |  | 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 | 
| Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST) |  | 30 days | 
| Number of patients demonstrating improvement in Seattle Heart Failure Model Score |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Bridge-to-transplant, circulatory support, VAD, IABP