TraNsvenous TrIcuspid Valve ReplacemenT with LuX-Valve Plus System (TRINITY-US)

Eligibility Criteria

• * Age ≥18 years at time of consent
• * Severe or greater TR assessed on transthoracic echocardiography by Echocardiography Core Lab using a 5-grade classification (Mild, Moderate, Severe, Massive, Torrential).
• * New York Heart Association (NYHA) Class II-IV
• * The Patient is being treated on optimal dosage for diuretics at investigator discretion
• * The Site Heart Team concur the patient is not an optimal candidate for surgical treatment and it is anatomically suitable for transcatheter tricuspid valve replacement
• * 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
• * Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core lab and Eligibility Committee
• * Left Ventricular Ejection Fraction (LVEF) \<35%
• * Pulmonary arterial systolic pressure (PASP) \>60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60mmHg); or Right 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.
• * Evidence of intracardiac mass, thrombus, or vegetation
• * Ebstein Anomaly or congenital right ventricular dysplasia
• * Surgical correction is indicated for other concomitant valvular disease (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
• * Active infection, infective endocarditis or sepsis within 3 months, or infections requiring antibiotics treatment within two weeks prior to 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
• * Any coronary or intracardiac or carotid intervention within 30 days prior to the planned procedure
• * Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support TRINITY-US Trial #: Ver 1.0, 14 Nov 2023, Confidential Page 7 of 8
• * Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
• * Active peptic ulcer or active gastrointestinal bleeding within prior 3 months to enrollment
• * Blood dyscrasias as defined: leukopenia (WBC \<1000 mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis, or coagulopathy
• * Inability to tolerate anticoagulation or antiplatelet therapy
• * Severe liver failure
• * Renal insufficiency (eGFR \<30 mL/min \[per the Cockcroft-Gault formula\] and/or renal replacement therapy)
• * Uncontrolled atrial fibrillation (e.g., resting heart rate \>120 bpm)
• * Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
• * Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiring continuous home oxygen
• * Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media
• * 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
• * Patients with current history of illicit drug use
• * Any other condition making it unlikely the patient will be able to complete all protocol procedure and follow-ups determined by the investigator