transvenous tricuspid valve replacement with lux-valve plus system (trinity-us)

Conditions: Tricuspid Regurgitation (TR)

Summary: the lux-valve plus system is intended for the treatment of patients with at least severe tr who are symptomatic and determined by a heart team not to be suitable for surgical treatment. this study aims to assess the safety and effectiveness of the lux-valve plus system in high-surgical risk patients with at least severe tricuspid regurgitation (tr).

investigational device: the lux-valve plus system consists of the following elements: 1. a bioprosthetic valve consistent of bovine pericardial tissue mounted on a self-expanding nitinol stent frame (hereafter referred to as lux-valve implant).the lux-valve implant consists of a trileaflet bovine-pericardial-tissue valve, a nitinol self-expanding stent, a fabric skirt, a pair of clips, an anchoring pin and sutures. 2. a catheter-based delivery system (hereafter referred to as lux-valve delivery device), 3. an introducer kit for transvenous access, and 4. a delivery system stabilizer. * the lux-valve implant sizes: o js/ttvi-28-40, js/ttvi-28-45, js/ttvi-28-50, js/ttvi- 28-55, js/ttvi-30-40, js/ttvi-30-45, js/ttvi-30-50, js/ttvi-30-55, js/ ttvi-30-60, js/ttvi-30-65 * lux--valve plus delivery system o js/ttvdj-33 * introducer kit o js/sid01-33-100 * stabilizer o js/sta-tj01-01 primary objective: to assess the safety and effectiveness of the lux-valve plus system in patients with at least severe tricuspid regurgitation (tr) who are at high risk for surgical treatment. study sites and geography: up to 3 centers in the united states. number of subjects: up to 15 subjects will be enrolled. indications for use: the lux-valve plus system is intended for the improvement of health status in patients with at least severe tr who are symptomatic and determined by a heart team to be at high risk for surgical treatment.

Eligibility 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

Keywords: tricuspid regurgitation transvenous tricuspid replacement lux-valve plus system