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

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.

Interventions

• Device LuxValve PLlus
  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.

Primary outcome measures

• A composite endpoint of Major Adverse Event (MAE) [Time frame: 1 year post-op]

Secondary outcome measures (12)

• Acute Device Success Rate [Time frame: At the end of Procedure]
• Procedural Success Rate [Time frame: At the end of Procedure]
• All-cause mortality [Time frame: 30-day and 1-year post-op]
• Heart failure hospitalization [Time frame: 30-day and 1-year post-op]
• NYHA Functional Class [Time frame: 30-day and 1-year post-op]
• Distance of 6-Minute Walk Test [Time frame: 30-day and 1-year post-op]
• Kansas City Cardiomyopathy Questionnaire [Time frame: 30-day and 1-year post-op]
• TR Severity [Time frame: Baseline, day 1, day 30, 6-month, 1-year]
• Mean Tricuspid valve inflow gradient [Time frame: Baseline, day 1, day 30, 6-month, 1-year]
• Right Atrial Volume [Time frame: Baseline, day 1, day 30, 6-month, 1-year]
• TAPSE [Time frame: Baseline, day 1, day 30, 6-month, 1-year]
• Right ventricular functions assessments [Time frame: Baseline, day 1, day 30, 6-month, 1-year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• Prince of Wales Hospital — Hong Kong

Identifiers

NCT: NCT06714500 · 2023.029

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗