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

NCT05436028 | Completed DMC

• 1 other identifier: JSNL-CIP-TVS02-01CE
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

  30 days post procedure

Secondary Outcomes (27)

• Acute Secondary Endpoints-Device Success Rate

  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

  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

  at 30 days

• Clinical and Functional Endpoints-All-cause mortality

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

• Clinical and Functional Endpoints-Cardiovascular mortality

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

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Transcatheter Tricuspid Valve Intervention

Interventions

Transcatheter Tricuspid Valve Intervention 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.

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥50 years at time of consent
• Severe or greater TR (≥3+) assessed on transthoracic echocardiography by Echo Core Lab (ECL) using a 5-grade classification
• New York Heart Association (NYHA) Class II-IV
• In the judgment of the Site Heart Team, the subject has been adequately treated per applicable standards, including optimal medical therapy with diuretics
• 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.
• 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
• In France, patient is affiliated to a health social security regimen or equivalent

You may not qualify if:

• 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.
• Left Ventricular Ejection Fraction (LVEF) \<35%
• Evidence of intracardiac mass, thrombus or vegetation
• Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
• Ebstein Anomaly or congenital right ventricular dysplasia
• 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.
• Patients with valve prostheses implanted in the tricuspid valve
• Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction
• Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the 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
• Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
• Active peptic ulcer or active gastrointestinal (GI) bleeding within prior 3 months to enrollment
• Inability to tolerate anticoagulation or antiplatelet therapy

Sponsors & Collaborators

• Jenscare Scientific: lead

Study Sites (1)

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

Bordeaux, Gironde, 33000, France

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 28, 2022
• Study Start: May 23, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)