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

Recruitment & Eligibility

Status: Not yet recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion 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 Exclusion Criteria: - 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