The purpose of this feasibility study is to assess the preliminary safety and clinical performance 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
A mechanical circulatory support device using the principles of counterpulsation.
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGSurvival to transplant or stroke-free survival
Time frame: 30 days
Number of patients who deteriorate requiring escalation of treatment
Time frame: 30 days
Rate of occurrence of all adverse events
Time frame: 30 days
Rate of occurrence of procedure-related adverse events
Time frame: 30 days
Rate of occurrence of serious device-related adverse events
Time frame: 30 days
Number of patients demonstrating improvement in NYHA Classification
Time frame: 30 days
Number of patients demonstrating improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) - quality of life (QOL)
Time frame: 30 days
Number of patients demonstrating improvement six minute walk test (6MWT) and two minute step test (2MST)
Time frame: 30 days
Number of patients demonstrating improvement in Seattle Heart Failure Model Score
Time frame: 30 days
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Advent Health
Orlando, Florida, United States
RECRUITINGUniversity of Chicago Medicine
Chicago, Illinois, United States
RECRUITINGNorthShore University Health System
Evanston, Illinois, United States
RECRUITINGSaint Vincent Hospital
Indianapolis, Indiana, United States
RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
RECRUITINGOchsner Clinic Foundation
New Orleans, Louisiana, United States
RECRUITINGBrigham & Women's Hospital
Boston, Massachusetts, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGSaint Luke's Mid-America Heart Institute
Kansas City, Missouri, United States
COMPLETED...and 8 more locations