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

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

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

Recruiting
18-99 years
Female
Phase N/A
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. 
Study details
    acne
    cardiology
    heart failure

TX6695

19 February 2024

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