FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation

This first-in-human study evaluates the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with degenerative mitral regurgitation. The study will enroll patients who are at high or prohibitive risk for conventional surgical repair or replacement of the mitral valve. Participants will receive implantation of the Vesalius TMVr System and will be followed to assess clinical outcomes, device performance, and any adverse events.

NCT Number	NCT07470788
Lead Sponsor	Vesalius Cardiovascular Inc.
Conditions	Degenerative Mitral Regurgitation
Enrollment	5 participants
Start Date	2026-03
Primary Completion	2032-04 (estimated)
Study Completion	2032-04 (estimated)
Updated on ClinicalTrials.gov	2026-03-13