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

NCT ID: NCT05436028

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2024-11-30

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.

Conditions

Tricuspid Regurgitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LuX-Valve Plus transvenous tricuspid valve and delivery system（LuX-Valve Plus System）

The LuX-Valve Plus System is intended for the treatment of patients with at least severe TR who are determined by a Heart Team to be at high risk of traditional open-heart surgery.

Group Type: EXPERIMENTAL

Transcatheter Tricuspid Valve Intervention

Intervention Type: DEVICE

Due to unsustainable effect of medical therapy and high risks of surgical treatment, transcatheter tricuspid valve intervention (TTVI) has been a major field of study in the world in the last 10 years. TTVI could potentially reduce TR with lower periprocedural risk and improve the patient's clinical status and prognosis. Per the ESC guidelines for surgical and interventional treatment of tricuspid regurgitation (2021 ESC/EACTS Guidelines for the Management of Valvular Heart Disease), Transcatheter intervention for symptomatic secondary severe TR may be considered in inoperable patients at a Heart Valve Centre with expertise in the treatment of tricuspid valve disease (Class IIb).

Transcatheter tricuspid treatment options can be divided into categories based on their mechanism of action: coaptation enhancement (edge-to-edge repair and spacer device), annuloplasty devices, caval valve implantation and valve replacement.

Interventions

Transcatheter Tricuspid Valve Intervention

Due to unsustainable effect of medical therapy and high risks of surgical treatment, transcatheter tricuspid valve intervention (TTVI) has been a major field of study in the world in the last 10 years. TTVI could potentially reduce TR with lower periprocedural risk and improve the patient's clinical status and prognosis. Per the ESC guidelines for surgical and interventional treatment of tricuspid regurgitation (2021 ESC/EACTS Guidelines for the Management of Valvular Heart Disease), Transcatheter intervention for symptomatic secondary severe TR may be considered in inoperable patients at a Heart Valve Centre with expertise in the treatment of tricuspid valve disease (Class IIb).

Transcatheter tricuspid treatment options can be divided into categories based on their mechanism of action: coaptation enhancement (edge-to-edge repair and spacer device), annuloplasty devices, caval valve implantation and valve replacement.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jenscare Scientific

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Unité Médico-Chirurgicale, Hôpital Haut Lévêque, CHU de Bordeaux

Bordeaux, Gironde, France

Countries

France

Other Identifiers

JSNL-CIP-TVS02-01CE

Identifier Type: -

Identifier Source: org_study_id