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

Inclusion Criteria:

• Age ≥18 years at time of consent

• Severe or greater TR assessed on transthoracic echocardiography by EchocardiographyCore 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 investigatordiscretion

• The Site Heart Team concur the patient is not an optimal candidate for surgicaltreatment and it is anatomically suitable for transcatheter tricuspid valvereplacement

• Patient must be able to fully understand all aspects of the investigation that arerelevant to the decision to participate and provide a written informed consent

• Anatomical inclusion criteria confirmed by echocardiographic core lab, CT core laband Eligibility Committee

Exclusion Criteria:

• Left Ventricular Ejection Fraction (LVEF) <35%

• Pulmonary arterial systolic pressure (PASP) >60 mmHg by echo Doppler (unless rightheart catheterization [RHC] demonstrates PASP ≤60mmHg); or Right heartcatheterization OR PASP >2/3 systemic BP with PVR >5 Wood units after vasodilatorchallenge, 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 (subjectswith concomitant valvular disease may treat their respective valve first and wait 2months 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 clinicallysignificant prosthetic dysfunction

• Active infection, infective endocarditis or sepsis within 3 months, or infectionsrequiring 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 priorto the planned procedure

• Any percutaneous coronary, intracardiac or carotid intervention within 30 days priorto the planned procedure

• Any coronary or intracardiac or carotid intervention within 30 days prior to theplanned procedure

• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, ormechanical 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 toenrollment

• Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (plateletcount <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 renalreplacement therapy)

• Uncontrolled atrial fibrillation (e.g., resting heart rate >120 bpm)

• Pregnancy or intent to become pregnant prior to completion of all protocol follow-uprequirements

• Severe Chronic Obstructive Pulmonary Disease requiring steroids or requiringcontinuous home oxygen

• Untreatable hypersensitivity or contraindication to any of the following: allantiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovinetissue, glutaraldehyde, or contrast media

• Estimated life expectancy <12 months.

• Subjects currently participating in another clinical trial of an investigationaldrug 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 allprotocol procedure and follow-ups determined by the investigator