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

A First-in-Human Investigational Testing Authorization Study Evaluating the Safety and Performance of the Vesalius Transcatheter Mitral Valve Repair System in Patients With Severe, 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.

This first-in-human study is designed to evaluate the safety and performance of the Vesalius Transcatheter Mitral Valve Repair (TMVr) System in patients with symptomatic, severe or moderate-to-severe degenerative mitral regurgitation who are at elevated surgical risk. The study will enroll up to five patients in Canada to assess procedural feasibility, technical performance, and short-term clinical outcomes following device implantation. Endpoints are based on Mitral Valve Academic Research Consortium (MVARC) definitions, including measures of procedural and device success, freedom from major adverse events, and technical achievement of device deployment. Safety, functional, and hemodynamic parameters will be monitored at predefined intervals, and follow-up will include assessment of valve function, adverse events, and device performance. This study will provide preliminary data to support the further development and evaluation of the Vesalius TMVr System.

Inclusion Criteria:

1. Age ≥ 19 years
2. Moderate to severe (≥3+) or severe (≥4+) degenerative mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines, depicted in Figure 14)
3. New York Heart Association (NYHA) Functional Class II, III, or Ambulatory (IV)
4. 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
5. Suitable anatomy for the Vesalius TMVr System as determined by pre-procedure imaging
6. Willing to adhere to study follow-up schedule for up to 5 years
7. Written informed consent provided

Exclusion Criteria:

1. Anatomy ideally suitable for other approved transcatheter therapy (i.e. TEER candidate)
2. LV ejection fraction < 30%
3. Active bacterial endocarditis within 60 days of planned index procedure
4. Dialysis-dependent renal insufficiency
5. Body Mass Index (BMI) ≥ 45 kg/m2
6. Previous valvular surgery
7. Previous atrial septal surgery
8. Previous endovascular structural procedure(s) and/or device(s) within 6 months
9. Severe mitral annular calcification (MAC) prohibiting device implantation
10. Severe annulus or leaflet calcification
11. Leaflet perforation
12. Contraindication to anticoagulation / antiplatelet therapy
13. Patients with sensitivity to nickel or contrast media
14. Concomitant severe tricuspid regurgitation
15. Absence of conventional medial and lateral papillary muscle groups
16. Femoral vein cannot accommodate a 29 F catheter
17. Contraindication to Transoesophageal echocardiography (TEE)
18. Life expectancy <1 year due to non-cardiac comorbidities.
19. 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
20. Participation in other clinical investigation
21. Pregnant or planning to become pregnant