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.
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
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
Dialysis-dependent renal insufficiency
Single group
Transcatheter Mitral Valve Repair
DeviceThe Vesalius Transcatheter Mitral Valve Repair (TMVr) System is a novel transcatheter device designed to percutaneously deliver an implant to repair the native mitral valve in patients with degenerative mitral regurgitation. The system uses an adjustable ePTFE net to reduce or eliminate mitral regurgitation. The device is delivered via a minimally invasive transcatheter approach, allowing precise positioning and deployment in high-risk patients not suitable for conventional surgery.
Safety - Number of Participants Experiencing All-Cause Mortality
Number of participants experiencing all-cause mortality post-implant, prior to discharge, and through the 30-day follow-up period.
Number of Participants Achieving Technical Success
Number of participants achieving successful delivery and positioning of the device, absence of procedural mortality, and freedom from emergency cardiovascular surgery or reintervention related to the device through procedure exit.
Number of participants Achieving Device Success
Number of patients achieving successful deployment and correct anatomical positioning of the device, absence of procedural mortality or stroke, and freedom from unplanned surgical or interventional procedures related to the device through 30 days.
Number of Participants by Mitral Regurgitation (MR) Severity Grade
Assessment of MR severity evaluated by transthoracic/transesophageal echocardiography (TTE/TEE). MR severity is categorized using standard clinical grading: Grade 0 (None/Trace), Grade 1+ (Mild), Grade 2+ (Moderate), Grade 3+ (Severe), and Grade 4+ (Very Severe). Higher grades indicate worse outcome severity.
Number of Participants Experiencing Major Adverse Events (MAE)
Occurrence of serious cardiovascular, cerebrovascular, or renal events related to the device or procedure.
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