Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System (LuxValve)

Transcatheter Tricuspid Valve Replacement Using the Lux-Valve Plus System for Patients With No Other Interventional Option: A Compassionate Use Study

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 Overview

• Status: Enrolling by invitation
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: LuxValve PLlus

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin
    • Hong Kong, Shatin, Hong Kong, 0000
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At the end of Procedure
All-cause mortality	30-day and 1-year all-cause mortality	30-day and 1-year post-op
Heart failure hospitalization	30-day and 1-year Heart failure hospitalization	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	30-day and 1-year post-op
Distance of 6-Minute Walk Test	Distance of 6-Minute Walk Test in meters	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	30-day and 1-year post-op
TR Severity	TR Severity assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
Mean Tricuspid valve inflow gradient	Mean Tricuspid valve inflow gradient assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
Right Atrial Volume	Right Atrial Volume assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
TAPSE	TAPSE assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments	Right ventricular functions assessments assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments: fractional area change（FAC）	Right ventricular functions assessments: fractional area change（FAC）assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments: systolic tricuspid lateral annular tissue velocity S'	Right ventricular functions assessments: systolic tricuspid lateral annular tissue velocity S' assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
Right ventricular functions assessments: Hepatic vein flow reversal	Right ventricular functions assessments: Hepatic vein flow reversal assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
Systolic pulmonary artery pressure	Systolic pulmonary artery pressure assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
Left Ventricular Ejection Fraction (LVEF)	Left Ventricular Ejection Fraction (LVEF) assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year
Paravalvular leak severity	Paravalvular leak severity assessed by echocardiography	Baseline, day 1, day 30, 6-month, 1-year

Collaborators and Investigators

• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong
• Investigators: Principal Investigator: Kent So, PI, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 26, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: 2023.029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No