A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement (NCT05436028) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement
France161 participantsStarted 2023-05-23
Plain-language 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.
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.
Up to 150 subjects will be implanted at up to 24 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 to3 per site, may be implanted by operators without prior experience using the LuX-Valve Plus device to gain hands-on experience.Each site has a maximum of 3 roll-in cases. The data of roll-in subjects will not count towards the overall enrollment cap. Safety and performance results of roll-in subjects will be analyzed in subgroups.
All subjects will be evaluated at baseline, procedure, discharge, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure
✕. 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