A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement

Jenscare Scientific

Status: Enrolling

Conditions: Tricuspid Regurgitation

Treatments: Device: Transcatheter Tricuspid Valve Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT05436028

JSNL-CIP-TVS02-01CE

Details and patient eligibility

About

This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic severe or greater TR in patients who are deemed high risk for tricuspid surgery.

Treatment with the LuX-Valve Plus system may enable patients with tricuspid regurgitation to have a complete tricuspid valve replacement with a minimally invasive approach.

A total of 93 subjects will be enrolled at up to 20 institutions worldwide. No single institution will be allowed to register more than 25% of total subjects. There is no minimum number of subjects to be registered at any site.

Up to an additional 42 roll-in subjects, up to 3 per site, may be enrolled by operators without prior experience with the LuX-Valve Plus system to gain hands-on experience. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and effectiveness results of roll-in subjects will be reported separately.

All subjects will be evaluated at baseline, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post-procedure

Enrollment: 135 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥50 years at time of consent
2. Severe or greater TR (≥3+) assessed on transthoracic echocardiography by Echo Core Lab (ECL) using a 5-grade classification
3. New York Heart Association (NYHA) Class III or IV
4. In the judgment of the Site Heart Team, the subject has been adequately treated per applicable standards, including optimal medical therapy with diuretics
5. The Site Heart Team determined that the subject is appropriate for transcatheter tricuspid valve replacement, and the subject is at high risk for tricuspid valve surgery
6. Subject must provide written informed consent prior to any trial related procedure

Exclusion criteria

1. Systolic pulmonary artery pressure (sPAP) > 60 mmHg assessed by echocardiography
2. Left Ventricular Ejection Fraction (LVEF) <40%
3. Evidence of intracardiac mass, thrombus or vegetation
4. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
5. Ebstein Anomaly or congenital right ventricular dysplasia
6. 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.
7. Pre-existing prosthetic valve(s) with clinically significant prosthetic dysfunction
8. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
9. Untreated clinically significant coronary artery disease requiring revascularization
10. Acute myocardial infarction or unstable ischemia-related angina within prior 30 days
11. Any percutaneous coronary, intracardiac or carotid intervention within 30 days
12. Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
13. Active peptic ulcer or active gastrointestinal (GI) bleeding within prior 3 months to enrollment
14. Inability to tolerate anticoagulation or antiplatelet therapy
15. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
16. Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening
17. Chronic liver failure or cirrhosis with MELD-Albumin Score ≥ 12
18. Severe lung disease or patient dependent on home oxygen and deemed unsuitable by the local heart team or eligibility committee for the study.
19. Futility with estimated life expectancy<12 months.
20. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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135 participants in 1 patient group

LuX-Valve Plus transvenous tricuspid valve and delivery system（LuX-Valve Plus System）

Experimental group

Description:

The LuX-Valve Plus System is intended for the treatment of patients with severe TR who are determined by a Heart Team to be at high risk of traditional open-heart surgery.

Treatment:

Device: Transcatheter Tricuspid Valve Intervention