A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement

Inclusion criteria

• Age≥50 years at time of consent
• Severe or greater TR (≥3+) assessed on transthoracic echocardiography by Echo Core Lab (ECL) using a 5-grade classification
• New York Heart Association (NYHA) Class II-IV
• In the judgment of the Site Heart Team, the subject has been adequately treated per applicable standards, including optimal medical therapy with diuretics
• The Site Heart Team concur the benefit-risk analysis supports transcatheter tricuspid valve replacement per current guidelines for the management of valvular heart disease, and the subject is at high risk for tricuspid valve surgery.
• Patient must be able to fully understand all aspects of the investigation that are relevant to the decision to participate, and provide a written informed consent
• In France, patient is affiliated to a health social security regimen or equivalent

Exclusion criteria

• Pulmonary arterial systolic pressure (PASP) > 60 mmHg by echo Doppler (unless right heart catheterization [RHC] demonstrates PASP ≤60 mmHg) or R heart catheterization OR PASP > 2/3 systemic BP with PVR > 5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP < 90 mmHg.
• Left Ventricular Ejection Fraction (LVEF) <35%
• Evidence of intracardiac mass, thrombus or vegetation
• Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
• Ebstein Anomaly or congenital right ventricular dysplasia
• 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.
• Patients with valve prostheses implanted in the tricuspid valve
• Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction
• Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
• Untreated clinically significant coronary artery disease requiring revascularization
• Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure
• Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure
• Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
• Active peptic ulcer or active gastrointestinal (GI) bleeding within prior 3 months to enrollment
• Inability to tolerate anticoagulation or antiplatelet therapy
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening
• Chronic liver failure or cirrhosis with MELD-Albumin Score ≥ 12
• Severe lung disease or patient dependent on home oxygen and deemed unsuitable by the local heart team or eligibility committee for the study.
• Futility with estimated life expectancy<12 months.
• Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
• Pregnant or lactating; or female of childbearing potential with a positive pregnancy test within 14 days prior to intervention (contraceptive requirement is shown in Appendix XI)
• Allergic to one or more of the substances contained in the implant and/or delivery system, including nitinol, tantalum, PET, PTFE, bovine pericardium, Pebax, PA, Polyurethane, Stainless steel.