Robotic transjugular tricuspid valve replacement using the Lux-valve plus system.
Robotic Transjugular Transcatheter Tricuspid Valve Replacement
This trial tests a robotic transjugular procedure using the Lux-valve plus to replace the tricuspid valve in adults with severe symptomatic tricuspid regurgitation who are high risk for open surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Prince of Wales Hospital, Shatin, Hong Kong Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shatin) |
| Trial ID | NCT07516145 on ClinicalTrials.gov |
What this trial studies
This interventional, single-center trial uses a novel intracardiac robotic platform that combines a high-dexterity, load-capacity catheter, a modular concentric robotic base, and an augmented reality navigation interface to deliver the Lux-valve plus via a transjugular approach. Eligible adults have severe symptomatic tricuspid regurgitation, are judged high risk for conventional tricuspid surgery by a multidisciplinary heart team, and have anatomy suitable for the device. Procedures are performed percutaneously at Prince of Wales Hospital with imaging guidance and robotic-assisted catheter manipulation to optimize valve positioning and deployment. The trial will track procedural success, safety events, and valve function over follow-up to determine feasibility and early outcomes.
Who should consider this trial
Good fit: Adults aged 18–90 with severe symptomatic tricuspid regurgitation who are deemed high surgical risk and have anatomy compatible with transjugular Lux-valve plus implantation are the intended candidates.
Not a fit: Patients with prior tricuspid repair or replacement that would interfere with the device, severe pulmonary hypertension, LVEF <40%, intracardiac thrombus or vegetation, unsuitable anatomy for device delivery, or who are pregnant or nursing are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the robotic approach could offer safer, more precise tricuspid valve replacement for high-risk patients while reducing operator radiation exposure and procedure time.
How similar studies have performed: Transcatheter tricuspid valve replacement with other valve systems has shown promising early results, but using a robotic intracardiac platform for transjugular TTVR is novel and has limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-90 * Severe symptomatic TR * Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists) and * Anatomically feasible for transjugular transcatheter tricuspid valve replacement using the Lux-valve plus system * Able to consent Exclusion Criteria: * Prior TV repair or replacement that would interfere with Lux-valve plus implantation * severe pulmonary hypertension (pulmonary artery systolic pressure \>70 mm Hg or \>2/3 systemic with pulmonary vascular resistance \>5 WU after vasodilator challenge) * Pregnant or nursing patients and those who plan pregnancy during the study period. Female patients of childbearing potential must have a negative pregnancy * Left Ventricular Ejection Fraction (LVEF) \<40% or; * Evidence of intracardiac mass, thrombus or vegetation or; * Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT or; * 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. * Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure or; * Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy or; * Underwent any cardiac or non-cardiac interventional or surgical procedure within 30 days prior to the procedure or planned to have the interventional or surgical procedure within 60 days after implant procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, etc); * Recent (within 90 days prior to procedure) stroke, transient ischemic attack, or myocardial infarction; * Life expectancy is less than 1 year; * Current participation in another investigational drug or device study.
Where this trial is running
Shatin
- Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Daniel Xu
- Email: xjldaniel@gmail.com
- Phone: 852 35051518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.