NCT05436028 - A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement | Crick

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age≥50 years at time of consent 2. Severe or greater TR (≥3+) assessed on transthoracic echocardiography by Echo Core Lab (ECL) using a 5-grade classification 3. New York Heart Association (NYHA) Class II-IV 4. In the judgment of the Site Heart Team, the subject has been adequately treated per applicable standards, including optimal medical therapy with diuretics 5. The Site Heart Team concur the benefit-risk analysis supports transcatheter tricuspid valve replacement per current guidelines for the management of valvular heart disease, and the subject is at high risk for tricuspid valve surgery. 6. 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 7. In France, patient is affiliated to a health social security regimen or equivalent Exclusion Criteria: 1. Pulmonary arterial systolic pressure (PASP) \> 60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60 mmHg) or R 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. 2. Left Ventricular Ejection Fraction (LVEF) \<35% 3. Evidence of intracardiac mass, thrombus or vegetation 4. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT 5. Ebstein Anomaly or congenital right ventricular dysplasia 6. Surgical correction is indicated for other concomitant valvular disease (e.g., severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation) Subjects with concomitant valvular disease may treat their respective valve first, and wait 2 months before being reassessed for the trial. 7. Patients with valve prostheses implanted in the tricuspid valve 8. Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction 9. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure 10. Untreated clinically significant coronary artery disease requiring revascularization 11. Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure 12. Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure 13. Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment 14. Active peptic ulcer or active gastrointestinal (GI) bleeding within prior 3 months to enrollment 15. Inability to tolerate anticoagulation or antiplatelet therapy 16. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support 17. Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening 18. Chronic liver failure or cirrhosis with MELD-Albumin Score ≥ 12 19. Severe lung disease or patient dependent on home oxygen and deemed unsuitable by the local heart team or eligibility committee for the study. 20. Futility with estimated life expectancy\<12 months. 21. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint. 22. Pregnant or lactating; or female of childbearing potential with a positive pregnancy test within 14 days prior to intervention (contraceptive requirement is shown in Appendix XI) 23. Allergic to one or more of the substances contained in the implant and/or delivery system, including nitinol, tantalum, PET, PTFE, bovine pericardium, Pebax, PA, Polyurethane, Stainless steel.

Outcomes

Primary Outcomes

A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure

A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure, as listed below: Cardiovascular Mortality Myocardial Infarction (MI) Stroke New onset renal failure requiring unplanned dialysis or renal replacement therapy Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by MVARC) Non-selective tricuspid valve surgery or transcatheter re-intervention post procedure Major cardiac structural complications Major access site and vascular complications Device-related pulmonary embolism New pacemaker implantation due to AV block

Time frame: 30 days post procedure

Secondary Outcomes

Acute Secondary Endpoints-Device Success Rate

Device success is defined as successful deployment of the device and removal of the delivery system as planned, with no unplanned surgery related to the device or access procedure.

Time frame: From the first skin incision for the investigational device to the time patient's exist from OR/Cath lab,assessed up to 24 hours post procedure.

Acute Secondary Endpoints-Procedural Success Rate

Device success without clinically significant PVL, as determined by the Echo Core Lab (ECL) assessment of a discharge TTE. Subjects who die or undergo tricuspid valve surgery before discharge are procedure failures.

Time frame: 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure

Acute Secondary Endpoints-Clinical Success Rate at 30 days

Procedural success without MAEs at 30 days.

Time frame: at 30 days

Clinical and Functional Endpoints-All-cause mortality

All-cause mortality

Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure

Clinical and Functional Endpoints-Cardiovascular mortality

Cardiovascular mortality

Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure

Clinical and Functional Endpoints-Heart failure hospitalization

Heart failure hospitalization

Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure

Clinical and Functional Endpoints-Tricuspid valve surgery or transcatheter re-intervention

Tricuspid valve surgery or transcatheter re-intervention

Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure

Clinical and Functional Endpoints-NYHA Functional Class

NYHA Functional Class

Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure

Clinical and Functional Endpoints-Distance of 6-Minute Walk Test (6MWT)

Distance of 6-Minute Walk Test (6MWT)

Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure

Clinical and Functional Endpoints-Kansas City Cardiomyopathy Questionnaire (KCCQ)

Kansas City Cardiomyopathy Questionnaire (KCCQ)：Scores are transformed to a range of 0-100,in which higher scores reflect better health status.

Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure

Clinical and Functional Endpoints-Edema assessment

Edema assessment (1+ to 4+)

Time frame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure

Echocardiographic Endpoints-TR Severity Grade

TR Severity Grade