A Clinical Study to Evaluate Ambulatory Counterpulsation for the Treatment of Advance Heart Failure: A Feasibility Study

Brief description of study

This study will evaluate a device called the NuPulseCV intravascular ventricular assist system (iVAS) that is similar to an IABP. IABPs (intra-aortic balloon pump which is implanted through a major artery in your body) and VADs (ventricular assist device which is implanted via open heart surgery) are the most common devices used to help patients feel better and live longer. The IABP is a sausage shaped balloon that is inserted into the artery and sits in the chest portion of the aorta. It inflates while the heart relaxes. It acts like an extra heart pump. This helps with circulating blood in your body. The purpose of this study is to assess if the iVAS can help improve blood circulation, gain a better understanding of how this device could impact health, determine human interaction with the device, and assess the portability of this device. The NuPulseCV iVAS is an experimental device which means that it has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced heart failure in patients.

Clinical Study Identifier: s18-01316
ClinicalTrials.gov Identifier: NCT02645539
Principal Investigator: Deane E Smith.

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