A Prospective, Multi-center Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement - Trial NCT05436028

Timeline & Enrollment

Primary Outcome

A composite endpoint of Major Adverse Event (MAE) at 30 days post procedure

Summary

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

ICD-10 Classifications