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

TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation - SafetY and Clinical Performance

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.

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