Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System

Launched by PRINCE OF WALES HOSPITAL, SHATIN, HONG KONG · Nov 28, 2024

Keywords

ClinConnect Summary

This study is testing the LuxValve Plus, a new device to replace the tricuspid valve in the heart for people with severe tricuspid regurgitation who are at high risk for open-heart surgery and don’t have other good transcatheter options. It’s a single-arm, compassionate-use study meaning there’s no comparison group, and it’s being done at Prince of Wales Hospital in Hong Kong with an estimated 20 adult participants. The device is inserted through a vein in the neck, and the study aims to see if it can be safely and effectively used in this group.

Eligible participants are adults aged 50 to 90 who have severe, symptomatic tricuspid regurgitation (meaning noticeable symptoms despite good medical therapy and limited daily activity, NYHA class III-IV) and are judged high risk for surgery by a heart team. Exclusions include very high pulmonary pressure, reduced heart pumping function, blood clots or infection inside the heart, anatomy unsuitable for the device, or other valve problems that require conventional surgery. Participants can expect one procedure followed by follow-up visits up to 1 year to monitor symptoms, heart function, and quality of life, with safety checks for major adverse events. Results are not yet available as the trial is ongoing.

Gender

ALL

Eligibility criteria

• 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.