This study focuses on people who were diagnosed with symptomatic severe tricuspid valve leakage. The purpose of this study is to learn whether an experimental device called the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement (TTVR) System (or MonarQ TTVR System) is safe and efficient to treat a leaky tricuspid valve. The tricuspid valve is 1 of 4 valves in the heart. When this valve is not working properly, it does not close tightly enough and can cause a leak; therefore, the blood will flow in both directions, causing less blood to flow into the lungs. The MonarQ device is a valve system that is designed to be implanted into the patient’s heart to replace the diseased native valve and eventually reduce or stop leaking of the valve. This study is an early feasibility study, meaning the experimental device will be used in a small number of patients.
What is the full name of this clinical trial?
A Clinical Study of the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System