FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation (NCT07470788) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
FIH ITA Study - Vesalius TMVr System for Symptomatic Degenerative Mitral Regurgitation
Canada5 participantsStarted 2026-03
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Age ≥ 19 years
✓. Moderate to severe (≥3+) or severe (≥4+) degenerative mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines, depicted in Figure 14)
✓. New York Heart Association (NYHA) Functional Class II, III, or Ambulatory (IV)
✓. Elevated risk for surgical mitral valve repair: Society of Thoracic Surgery (STS) predicted risk of mortality (PROM) of ≥6% as determined by the STS Risk Calculator for Surgical Repair of Primary Mitral Regurgitation \[1\], as well as patient operative risk assessment by the Heart Team
✓. Suitable anatomy for the Vesalius TMVr System as determined by pre-procedure imaging
✓. Willing to adhere to study follow-up schedule for up to 5 years
✓. Written informed consent provided
Exclusion criteria
✕. Anatomy ideally suitable for other approved transcatheter therapy (i.e. TEER candidate)
✕. LV ejection fraction \< 30%
✕. Active bacterial endocarditis within 60 days of planned index procedure