Clinical Study of the inQB8 TTVR System

This study tests the safety and performance of the MonarQ tricuspid valve replacement system (inQB8), a minimally invasive device designed to replace a severely leaking tricuspid heart valve without open-heart surgery. The tricuspid valve controls blood flow on the right side of the heart, and severe leakage (regurgitation) can cause symptoms and heart failure. Eligible patients must have severe or greater tricuspid regurgitation, be hemodynamically stable, and have been adequately treated for heart failure, but not require emergency surgery or have refractory heart failure. Participation involves undergoing the valve replacement procedure and attending follow-up visits to assess how well the device is working and whether any complications occur. This summary was prepared using AI to help patients understand the study in plain language.