Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System

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

Keywords

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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.