Robotic Transjugular Transcatheter Tricuspid Valve Replacement

Exclusion Criteria

• •Prior TV repair or replacement that would interfere with Lux-valve plus implantation
• •severe pulmonary hypertension (pulmonary artery systolic pressure \>70 mm Hg or \>2/3 systemic with pulmonary vascular resistance \>5 WU after vasodilator challenge)
• •Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy
• •Left Ventricular Ejection Fraction (LVEF) \<40% or;
• •Evidence of intracardiac mass, thrombus or vegetation or;
• •Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT or;
• •Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation); Subjects with concomitant valvular disease may treat their respective valve first and wait 2 months before being reassessed for the trial.
• •Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure or;
• •Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy or;
• •Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, etc);
• •Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction;
• •Life expectancy is less than 1 year;
• •Current participation in another investigational drug or device study.