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โ† Trials
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Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System

RecruitingNAAges 50 Years - 90 YearsAllPrince of Wales Hospital, Shatin, Hong Kong
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In plain words

What the trial is, and whether it could suit you

Tricuspid regurgitation (TR) is a common disease, and the tricuspid valve (TV) is no longer a "forgotten valve". Open heart surgery for isolated TR is uncommonly performed due to high operative risk (8-10% mortality). However, TR is associated with increased morbidity and mortality. There exists an unmet clinical need for less invasive intervention to treat TR. Transcatheter edge to edge repair (TEER) is a technique that is shown to be safe and effective in TR reduction and is associated with significant symptom improvement. However, a significant portion of TV anatomy are not suitable to be treated with TEER (e.g. coaptation gap \>10mm). A wide variety of technologies has been developed in recent years. Transcatheter tricuspid valve replacement (TTVR) is one of the more promising option for tricuspid regurgitation (TR) patients at high risk for surgery. A previous study reported that tr

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • LuxValve PLlus
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Where

1 site
Prince of Wales Hospital
Hong Kong, Hong Kong
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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