NuPulse iVAS Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advanced Heart Failure: A Feasibility Study
Sponsor: |
NuPulse, Inc. |
Enrolling: |
Male and Female Patients |
Study Length: |
1 Years |
Clinic Visits: |
16 |
IRB Number: |
AAAS1409 |
U.S. Govt. ID: |
NCT02645539 |
Contact: |
Anel Paulino, Clinical Research Coordinator: (212) 305-3009 / ap3602@cumc.columbia.edu |
The purpose of this study is to evaluate the NuPulseCV intravascular ventricular assist system (iVAS), a device similar to an Intra-aortic Balloon Pump (IABP) that helps circulate blood from the heart throughout the rest of the body. This study aims to: (1) See if the iVAS improves your blood circulation (2) Better understand how the iVAS device could impact your health (3) Observe human interaction with the iVAS device (4) Assess the portability of the iVAS device. The NuPulseCV iVAS is an experimental device, which means that it has not yet been approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced heart failure in patients.
This study is closed
Investigator
Koji Takeda, MD, PhD
Are you 18 years of age or older? |
Yes |
No |
Do you have advanced heart failure? |
Yes |
No |