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

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