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

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Conditions studied: Degenerative Mitral Regurgitation

In brief

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.

Key facts

Study ID

NCT07470788

Run by

Vesalius Cardiovascular Inc.

People needed

5

Starts

2026-03-01

Expected to finish

2032-04-01

Last updated by the study team

2026-03-13

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Body Mass Index (BMI) ≥ 45 kg/m2
• Previous valvular surgery
• Previous atrial septal surgery
• Previous endovascular structural procedure(s) and/or device(s) within 6 months
• Severe mitral annular calcification (MAC) prohibiting device implantation
• Severe annulus or leaflet calcification
• Leaflet perforation
• Contraindication to anticoagulation / antiplatelet therapy
• Patients with sensitivity to nickel or contrast media
• Concomitant severe tricuspid regurgitation
• Absence of conventional medial and lateral papillary muscle groups
• Femoral vein cannot accommodate a 29 F catheter
• Contraindication to Transoesophageal echocardiography (TEE)
• Life expectancy <1 year due to non-cardiac comorbidities.
• Presence of other anatomic, comorbid conditions, or other medical conditions that could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results, in the opinion of the Heart Team
• Participation in other clinical investigation
• Pregnant or planning to become pregnant

Where it is running

• St. Paul's Hospital — Vancouver, Canada

Full record on ClinicalTrials.gov

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