Clinical trial NCT06714500: Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System
Official title: Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System for Patients With No Other Interventional Option: A Compassionate Use Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: A composite endpoint of Major Adverse Event (MAE)
timeFrame: 1 year post-op
Secondary outcomes:
measure: Acute Device Success Rate
timeFrame: At the end of Procedure
measure: Procedural Success Rate
timeFrame: At the end of Procedure
measure: All-cause mortality
timeFrame: 30-day and 1-year post-op
measure: Heart failure hospitalization
timeFrame: 30-day and 1-year post-op
measure: NYHA Functional Class
timeFrame: 30-day and 1-year post-op
measure: Distance of 6-Minute Walk Test
timeFrame: 30-day and 1-year post-op
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: 30-day and 1-year post-op
measure: TR Severity
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: Mean Tricuspid valve inflow gradient
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: Right Atrial Volume
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: TAPSE
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: Right ventricular functions assessments
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: Right ventricular functions assessments: fractional area change（FAC）
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: Right ventricular functions assessments: systolic tricuspid lateral annular tissue velocity S'
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: Right ventricular functions assessments: Hepatic vein flow reversal
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: Systolic pulmonary artery pressure
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
measure: Paravalvular leak severity
timeFrame: Baseline, day 1, day 30, 6-month, 1-year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Shatin
Study officials:
affiliation: Chinese University of Hong Kong
name: Kent So, PI
role: PRINCIPAL_INVESTIGATOR
References: