Clinical trial NCT05436028: A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
Official title: TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT With LuX-Valve Plus System in Patients With Severe or Greater Tricuspid Regurgitation -- SafetY and Clinical Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: Jenscare Scientific
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 161
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery.

Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach.

Up to 150 subjects will be implanted at up to 24 institutions worldwide. No single institution will be allowed to register more than 25% of total subjects. There is no minimum number of subjects to be registered at any site.

Up to3 per site, may be implanted by operators without prior experience using the LuX-Valve Plus device to gain hands-on experience.Each site has a maximum of 3 roll-in cases. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and performance results of roll-in subjects will be analyzed in subgroups.

All subjects will be evaluated at baseline, procedure, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure.


Eligibility criteria: 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.

Primary outcomes:
measure: A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure
timeFrame: 30 days post procedure
Secondary outcomes:
measure: Acute Secondary Endpoints-Device Success Rate
timeFrame: 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.
measure: Acute Secondary Endpoints-Procedural Success Rate
timeFrame: 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure
measure: Acute Secondary Endpoints-Clinical Success Rate at 30 days
timeFrame: at 30 days
measure: Clinical and Functional Endpoints-All-cause mortality
timeFrame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Clinical and Functional Endpoints-Cardiovascular mortality
timeFrame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Clinical and Functional Endpoints-Heart failure hospitalization
timeFrame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Clinical and Functional Endpoints-Tricuspid valve surgery or transcatheter re-intervention
timeFrame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Clinical and Functional Endpoints-NYHA Functional Class
timeFrame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Clinical and Functional Endpoints-Distance of 6-Minute Walk Test (6MWT)
timeFrame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Clinical and Functional Endpoints-Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Clinical and Functional Endpoints-Edema assessment
timeFrame: at 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-TR Severity Grade
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Vena Contracta Width
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Regurgitation Jet Area
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Effective Regurgitant Orifice Area (EROA)
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Regurgitant Volume
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Mean Tricuspid valve inflow gradient
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Right Atrial Volume
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Right ventricular functions assessments:TAPSE
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Right ventricular functions assessments:fractional area change（FAC）
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Right ventricular functions assessments:systolic tricuspid lateral annular tissue velocity S'
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Right ventricular functions assessments:Hepatic vein flow reversal
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Right ventricular functions assessments:Inferior Cava Vein Diameter/respiratory variations
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Systolic pulmonary artery pressure
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Cardiac Output
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Left Ventricular Ejection Fraction (LVEF)
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
measure: Echocardiographic Endpoints-Paravalvular leak severity
timeFrame: at baseline, 7-day post procedure, or at discharge if the subjects are discharged within 7 days after the procedure, 30 days, 6 months, 12 months and annually until 5 years post-procedure
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Unité Médico-Chirurgicale, Hôpital Haut Lévêque, CHU de Bordeaux
state: Gironde
Study officials:
References: