LuX-Valve Plus System for Severe or Greater Tricuspid Regurgitation

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of a Transvenous Artificial Tricuspid Valve System in Patients With Severe or Greater Tricuspid Regurgitation

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Tricuspid Regurgitation (TR)
• Intervention / Treatment: Device: Transvenous Tricuspid Valve System implantation + OMT; Drug: OMT

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Cardiogenic shock or hemodynamic instability within 30 days
• Untreated severe CAD or ACS within 30 days
• Life expectancy ≤ 1 year
• Known allergy to device components or study drugs
• Pregnancy or lactation (or planned pregnancy)
• Enrolled in another interventional trial (not reached primary endpoint)
• Other conditions deemed unsuitable per investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; LuX-Valve Plus System+OMT	Device: Transvenous Tricuspid Valve System implantation + OMT; Transvenous tricuspid valve replacement with Lux-Valve Plus System in patients with severe or greater Tricuspid Regurgitation despite optimal medical therapy (OMT)
Other: Control Group; OMT only	Drug: OMT; Optimal medical therapy (OMT) as the control group for patients with severe or greater tricuspid regurgitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Alive;; No heart failure rehospitalization;; Reduction in tricuspid regurgitation severity by ≥1 grade from baseline;; 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

Collaborators and Investigators

• Sponsor: Jenscare Scientific

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Actual): March 6, 2026
• Study Completion (Estimated): August 6, 2030

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Transcatheter tricuspid valve replacement; Tricuspid Regurgitation (TR); TTVR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: CP-TVS02-C2401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No