Categorizing Patient Risk for Tricuspid Regurgitation (TR) Intervention With Admittance Pulmonary Artery Catheter System (APACS)

This study is an Early Feasibility Study (EFS) designed to evaluate the performance of the admittance PAC system for measuring RV hemodynamic data, including pressure-volume loops, in patients undergoing clinically indicated tricuspid valve (TV) replacement or clipping. The purpose of the device is to predict RV hemodynamic response prior to TV intervention and to generate preliminary data that may inform design iterations on the admittance PAC prior to device design lockdown.

A total of 8 subjects will be recruited from two clinical sites (4 subjects per site). Participants will be recruited from patients already scheduled to undergo clinically indicated TV intervention.

Data collected using the admittance PAC system will be used to inform design iterations of the invention for research purposes only and will not be shared with interventional cardiologists during the procedure or used to guide clinical decision-making. Standard-of-care right heart catheterization will be performed to obtain clinically required hemodynamic measurements, including right-side pressures and cardiac output. The standard right heart hemodynamics obtained by the admittance PAC will not be used clinically. The research protocol does not alter standard vascular access, sheath size, or procedural workflow beyond the additional data acquisition using the investigational device immediately prior to the interventional TV procedure.

Inclusion criteria

• Patients with severe or torrential TR who are already scheduled to undergo clinically indicated tricuspid valve (TV) percutaneous replacement or clipping to reduce heart failure symptoms

Exclusion criteria

• Children (defined as individual <18 years of age) will be excluded from this study