Study of the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System to Treat Severe Tricuspid Valve Regurgitation

What this Trial Is About

Researchers are evaluating the safety and performance of the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System in adults with tricuspid valve regurgitation. This multi-center, prospective, single-arm study focuses on participants who have severe or greater symptomatic tricuspid regurgitation and are hemodynamically stable, with adequately treated heart failure according to medical standards. Participants will receive treatment with the inQB8 MonarQ Tricuspid Valve Replacement System, which replaces the tricuspid valve using a transcatheter approach. The study does not include a comparison group and involves only the investigational device intervention. The treatment is delivered through a minimally invasive procedure designed to address the valve condition. During the study, participants will be monitored for major adverse events related to the device or procedure within 30 days, and changes in tricuspid regurgitation grade from baseline will be assessed at 30 days. Secondary measures include device and procedure-related complications, heart function classification, walking ability, health status, repeat assessments of valve regurgitation, and hospitalization rates, which will be evaluated at multiple time points up to about one year on average. Safety and performance data will be collected throughout the study period.

Clinical Study of the inQB8 TTVR System (The MonarQ Study)