Jenscare's LuX-Valve Plus tricuspid trial passes completion date with no results posted
The 126-patient pivotal device trial reached its March 2026 primary completion date, but the composite clinical success and safety data have not appeared on the registry.
Executive Summary
- A Chinese pivotal trial of a transcatheter tricuspid valve replacement device has reached its registered primary completion date at full enrollment, putting its composite clinical success and safety data next in line for disclosure.
- The trial carries two primary endpoints, a composite of survival, freedom from heart failure rehospitalization, regurgitation improvement, and functional class gain, alongside a 30-day major adverse event rate, so the readout must clear a bar on both efficacy and procedural safety at once.
- The device sits in a field of four direct comparators already in clinical testing for the same indication, none of which has a recorded termination, so the readout will land against peers that have so far cleared operational milestones rather than failed outright.
- Reaching full enrollment and moving to Active, not recruiting is the expected sequence for a device trial at this stage, not a signal of distress.
The trial
NCT07705594 is a Not Applicable-phase, registrational device study of the LuX-Valve Plus System, a transcatheter tricuspid valve replacement system, in patients with severe or greater tricuspid regurgitation. The trial enrolled 126 patients against a target of 126, reaching full enrollment, and its status reads Active, not recruiting. It started October 9, 2024, and its registered primary completion date was March 6, 2026, a date that has now passed; the trial's overall completion date extends to August 6, 2030 for longer-term follow-up. NCT07705594LuX-Valve Plus System for Severe or Greater Tricuspid RegurgitationNCT07705594
The endpoints
The trial registers two primary outcome measures. The first is composite clinical success at 6 months, defined as the patient being alive, free of heart failure rehospitalization, showing at least a 1-grade reduction in tricuspid regurgitation severity from baseline, and improving at least one NYHA functional class. The second is the rate of major adverse events, including cardiac death, stroke, major bleeding, tricuspid valve re-intervention, and new pacemaker implantation, measured at 30 days post-treatment. No results for either endpoint have posted on ClinicalTrials.gov. NCT07705594LuX-Valve Plus System for Severe or Greater Tricuspid RegurgitationNCT07705594
The competitive field
Four device programs share the same target and indication and are eligible direct comparators: Hangzhou Valgen Medtech's DragonFly-T System, Jenscare's own earlier LuX-Valve Plus study (NCT05436028), TRiCares' Topaz Transcatheter Tricuspid Valve Replacement System, and Mitralix's Mistral. None of the four sponsors in this target-indication pair has a recorded trial termination, and one prior trial in the same target-indication pairing has completed. A broader set of modality-precedent comparators, including Edwards Lifesciences' EVOQUE system and P+F Products' TricValve, use different device mechanisms within the same indication, widening the field beyond direct target-sharing peers. NCT07705594LuX-Valve Plus System for Severe or Greater Tricuspid RegurgitationNCT07705594
What the readout will establish
Jenscare runs three other tricuspid regurgitation trials with the LuX-Valve Plus System, including a U.S.-directed study (NCT06568003) still listed as Not yet recruiting and a Recruiting trial (NCT05436028) with a larger 150-patient target. A registrational device study of 126 patients with a composite functional endpoint and a 30-day safety endpoint is designed to support marketing authorization rather than to explore dose or mechanism, so the coming data will bear directly on whether the device's next regulatory and commercial steps in China proceed on schedule. NCT07705594LuX-Valve Plus System for Severe or Greater Tricuspid RegurgitationNCT07705594
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