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

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Updated on 19 February 2024

Summary

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 your health, determine human interaction with the device, and assess the portability of this device.

Description

You are being asked to participate because your physician has determined that you have advanced heart failure and require additional circulatory support. Your heart failure has progressed and the damage to your heart is preventing it from sufficiently pumping blood to the rest of your body. Your physician has determined that guideline directed medical therapy for your advanced heart failure is not working and that you may benefit from additional mechanical circulatory support with an intra-aortic balloon pump (IABP, which is implanted through a major artery in your body) or with a ventricular assist device (VAD, which is implanted via open heart surgery). IABPs and VADs 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 your 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 iVAS also has a skin interface device facilitating patient ambulation, which allows for increased mobility. This study will evaluate a device called the NuPulseCV intravascular ventricular assist system (iVAS) that is similar to an IABP. 

Details
Condition acne, cardiology, heart failure
Age 18years - 99years
Clinical Study IdentifierTX6695
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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