LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation

NCT07705594 | Active Not Recruiting

• 1 other identifier: CP-TVS02-C2401
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the safety and effectiveness of the Transvenous Artificial Tricuspid Valve System, LuX-Valve Plus System, Jenscare Scientific Co., Ltd. The study population consists of high-risk patients with severe or greater tricuspid regurgitation (TR) who are ineligible for surgical intervention and have demonstrated inadequate response to optimized medical therapy (OMT). This is a prospective, multicenter, randomized controlled trial. A total of 111 subjects who meet all inclusion criteria and none of the exclusion criteria will be enrolled. Participants will be randomized in a 2:1 ratio to one of the following groups: Treatment Group: Transvenous Artificial Tricuspid Valve System implantation + OMT Control Group: OMT alone All subjects will undergo serial follow-up assessments pre-treatment, during the treatment period, and post-procedure at 30 days, 3 months, 6 months, 1 year, and annually through 2-5 years. A summary report will be submitted to the regulatory authority at the 6-month time point. Subjects in the treatment group will have one extra follow-up visit at 7 days ± 3 days post-procedure or prior to discharge (whichever occurs first).

Conditions

Tricuspid Regurgitation (TR)

Keywords

Tricuspid Regurgitation (TR); Transcatheter tricuspid valve replacement; TTVR

Outcome Measures

Primary Outcomes (2)

• Incidence rate of composite endpoint events

  Percentage (%) of participants achieving composite clinical success at 6 months. Composite clinical success is defined as meeting all of the following criteria: 1. Alive; 2. No heart failure rehospitalization; 3. Reduction in tricuspid regurgitation severity by ≥1 grade from baseline; 4. Improvement in New York Heart Association (NYHA) functional class by ≥1 class from baseline.

  6 months post-treatment

• Rate of Major Adverse Events (MAE)

  The major adverse event (MAE) rate is defined as the occurrence of any of the following: Cardiac death Myocardial infarction Stroke New-onset renal failure requiring renal replacement therapy after the procedure Major bleeding (Grade ≥3b according to TVARC) Tricuspid valve re-intervention Device puncture site and vascular access complications Major cardiac structural complications Device-related pulmonary embolism Arrhythmia or conduction block requiring permanent pacemaker implantation

  30 Day Post-treatment

Study Arms (2)

Treatment Group

EXPERIMENTAL

LuX-Valve Plus System+OMT

Device: Transvenous Tricuspid Valve System implantation + OMT

Control Group

OTHER

OMT only

Drug: OMT

Interventions

Transvenous Tricuspid Valve System implantation + OMT DEVICE

Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)

Treatment Group

OMT DRUG

Optimal medical therapy (OMT) as the control group for patients with severe or greater tricuspid regurgitation

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Severe or greater TR (TR ≥ 3+ / 4+ by echocardiography)
• High surgical risk or inoperable per heart team (TRI-SCORE ≥6, STS ≥8%, EuroSCORE II ≥3%, etc.) AND symptomatic despite GDMT (≥1 month diuretics, stable regimen for ≥2 weeks)
• Suitable for TTVR per heart team
• NYHA III-IV
• Signed ICF and willing to comply with follow-up

You may not qualify if:

• Anatomy unsuitable for device procedure
• LVEF \< 50%
• SPAP \> 60 mmHg by TTE (unless RHC confirms ≤60 mmHg)
• Aortic/mitral/pulmonary valve disease requiring surgery
• Prosthetic valve replacement within 6 months or moderate/severe dysfunction
• Ebstein anomaly or RV dysplasia
• RVOT obstruction or intracardiac mass
• Active endocarditis within 90 days, or antibiotics for infection within 14 days
• CV/cardiac/cervical surgery within 30 days
• Stroke within 90 days
• Unable to tolerate anticoagulation/antiplatelet therapy
• eGFR \< 30 mL/min/1.73m² or on RRT
• MELD-Albumin ≥ 12
• Severe respiratory dysfunction (unsuitable for general anesthesia)
• Active GI bleeding/ulcer within 90 days

Sponsors & Collaborators

• Jenscare Scientific: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 15, 2026
• Study Start: October 9, 2024
• Primary Completion: March 6, 2026
• Study Completion (Estimated): August 6, 2030
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

CN (1)