Status:
COMPLETED
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
Lead Sponsor:
Jenscare Scientific
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This is a prospective, single-arm, multi-center trial to evaluate the LuX-Valve Plus system for treating symptomatic at least severe TR in patients who are deemed high risk for tricuspid surgery. Tre...
Eligibility Criteria
Inclusion
- Age≥50 years at time of consent
- Severe or greater TR (≥3+) assessed on transthoracic echocardiography by Echo Core Lab (ECL) using a 5-grade classification
- New York Heart Association (NYHA) Class II-IV
- In the judgment of the Site Heart Team, the subject has been adequately treated per applicable standards, including optimal medical therapy with diuretics
- The Site Heart Team concur the benefit-risk analysis supports transcatheter tricuspid valve replacement per current guidelines for the management of valvular heart disease, and the subject is at high risk for tricuspid valve surgery.
- Patient must be able to fully understand all aspects of the investigation that are relevant to the decision to participate, and provide a written informed consent
- In France, patient is affiliated to a health social security regimen or equivalent
Exclusion
- Pulmonary arterial systolic pressure (PASP) \> 60 mmHg by echo Doppler (unless right heart catheterization \[RHC\] demonstrates PASP ≤60 mmHg) or R heart catheterization OR PASP \> 2/3 systemic BP with PVR \> 5 Wood units after vasodilator challenge, in the absence of symptomatic hypotension or systolic BP \< 90 mmHg.
- Left Ventricular Ejection Fraction (LVEF) \<35%
- Evidence of intracardiac mass, thrombus or vegetation
- Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT
- Ebstein Anomaly or congenital right ventricular dysplasia
- 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.
- Patients with valve prostheses implanted in the tricuspid valve
- Pre-existing prosthetic valve(s) (other than tricuspid ones) with clinically significant prosthetic dysfunction
- Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure
- Untreated clinically significant coronary artery disease requiring revascularization
- Acute myocardial infarction or unstable ischemia-related angina within 30 days prior to the planned procedure
- Any percutaneous coronary, intracardiac or carotid intervention within 30 days prior to the planned procedure
- Cerebrovascular stroke (ischemic or bleeding) within prior 3 months to enrollment
- Active peptic ulcer or active gastrointestinal (GI) bleeding within prior 3 months to enrollment
- Inability to tolerate anticoagulation or antiplatelet therapy
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- Renal insufficiency (eGFR \< 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening
- Chronic liver failure or cirrhosis with MELD-Albumin Score ≥ 12
- Severe lung disease or patient dependent on home oxygen and deemed unsuitable by the local heart team or eligibility committee for the study.
- Futility with estimated life expectancy\<12 months.
- Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint.
- Pregnant or lactating; or female of childbearing potential with a positive pregnancy test within 14 days prior to intervention (contraceptive requirement is shown in Appendix XI)
- Allergic to one or more of the substances contained in the implant and/or delivery system, including nitinol, tantalum, PET, PTFE, bovine pericardium, Pebax, PA, Polyurethane, Stainless steel.
Key Trial Info
Start Date :
May 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT05436028
Start Date
May 23 2023
End Date
November 30 2024
Last Update
May 21 2025
Active Locations (1)
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1
Unité Médico-Chirurgicale, Hôpital Haut Lévêque, CHU de Bordeaux
Bordeaux, Gironde, France, 33000