Transcatheter Tricuspid Valve Replacement with the LuxValve Plus for High-Risk TR

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the LuxValve Plus system for transcatheter tricuspid valve replacement in patients with severe symptomatic TR who are deemed high risk for open surgery. Eligible participants have NYHA class III–IV symptoms despite optimized medical therapy and lack feasible alternatives with current transcatheter options. The trial focuses on device deployment feasibility, safety, and preliminary effectiveness, including symptom changes and functional status, in a real-world Hong Kong setting under a multidisciplinary team assessment. Exclusion criteria include high pulmonary pressures, reduced LV function, intracardiac masses, and anatomical or concomitant valvular conditions that would preclude device use. The study is conducted at Prince of Wales Hospital in Hong Kong and does not list additional collaborating sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 50- to 90-year-old
* Severe symptomatic tricuspid regurgitation (NYHA III-IV) despite optimal medical therapy
* Deem high risk for tricuspid valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists)
* Anatomically not feasible with other transcatheter tricuspid valve therapy that is commercially available in Hong Kong (i.e. TriClip System)
* Capacity to provide informed consent

Exclusion Criteria:

* Systolic pulmonary artery pressure (sPAP) \> 60 mmHg assessed by echocardiography
* Left Ventricular Ejection Fraction (LVEF) \<40%
* Evidence of intracardiac mass, thrombus or vegetation
* Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
* 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
* Active peptic ulcer or active gastrointestinal (GI) bleeding precluding anticoagulation or antiplatelet therapy
* Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.

Where it's running

• Prince of Wales Hospital
  Hong Kong, Shatin, Hong Kong Recruiting

Study contacts

• Principal investigator: Kent So, PI — Chinese University of Hong Kong
• Study coordinator: Daniel Xu, Nursing Officer
• Email: danielxu@cuhk.edu.hk
• Phone: 35051518

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults

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• Pivot Extend device to treat severe tricuspid regurgitation

  This trial will try the Pivot Extend device in adults with severe, symptomatic tricuspid regurgitation to see if it safely reduces valve leakage and improves symptoms.

  Recruiting Tau-MEDICAL Co., Ltd. · Macquarie Park, New South Wales · NCT07172477

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.