Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System

N/AEnrolling By InvitationNCT06714500

Prince of Wales Hospital, Shatin, Hong Kong20 enrolled

Overview

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 transcatheter tricuspid devices, which were employed with the radial force between the device and tricuspid annulus, were radial force-dependent. However, this radial force for valve fixation may cause complications, such as conduction block and right coronary artery impingement. The LuX-Valve (Jenscare Biotechnology) is a radial force-independent orthotopic TTVR device. The feasibility and efficacy of this device have been reported by several studies. However, this valve was implanted through right atrial access, where a small incision of the right chest and right atrium is needed. The LuX-Valve Plus valve replacement system is the second-generation version of the LuX-Valve and can be implanted through the jugular vein. The first-in-human implantation was recently performed. The study aims to assess the feasibility, safety and efficacy outcome of the Lux Valve Plus system in a cohort of otherwise no surgical option patients with severe symptomatic tricuspid regurgitation despite optimal medical therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Interventions

LuxValve PLlusDEVICE

The LuX-Valve (Jenscare Biotechnology) is a radial force-independent orthotopic TTVR device. The feasibility and efficacy of this device have been reported by several studies (11-13). However, this valve was implanted through right atrial access, where a small incision of the right chest and right atrium is needed. The LuX-Valve Plus valve replacement system is the second-generation version of the LuX-Valve and can be implanted through the jugular vein.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

A composite endpoint of Major Adverse Event (MAE)

A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure: Cardiovascular Mortality, Myocardial Infarction (MI), Stroke, New onset renal failure requiring unplanned dialysis or renal replacement therapy, Severe Bleeding (includes fatal, life-threatening and extensive bleeding as defined by VARC), Non-selective tricuspid valve surgery or transcatheter re-intervention post procedure, Major cardiac structural complications, Major access site and vascular complications, New pacemaker implantation due to AV block

Time frame: 1 year post-op

Secondary Outcomes

Acute Device Success Rate

successful deployment of the device and removal of the delivery system as planned, with no unplanned surgery related to the device or access procedure.

Time frame: At the end of Procedure

Procedural Success Rate

Device success without clinically significant PVL, as determined by the Echo Core Lab (ECL) assessment of a discharge TTE. Subjects who die or undergo tricuspid valve surgery before discharge are procedure failures.

Time frame: At the end of Procedure

All-cause mortality

30-day and 1-year all-cause mortality

Time frame: 30-day and 1-year post-op

Heart failure hospitalization

30-day and 1-year Heart failure hospitalization

Time frame: 30-day and 1-year post-op

NYHA Functional Class

NYHA Functional Class 2. Distance of 6-Minute Walk Test (6MWT) 3. Kansas City Cardiomyopathy Questionnaire (KCCQ)：Scores are transformed to a range of 0-100, in which higher scores reflect better health status

Time frame: 30-day and 1-year post-op

Distance of 6-Minute Walk Test

Distance of 6-Minute Walk Test in meters

Time frame: 30-day and 1-year post-op

Kansas City Cardiomyopathy Questionnaire

Kansas City Cardiomyopathy Questionnaire (KCCQ)：Scores are transformed to a range of 0-100, in which higher scores reflect better health status

Time frame: 30-day and 1-year post-op

TR Severity

TR Severity assessed by echocardiography