Degenerative Mitral Regurgitation
Conditions
Brief 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.
Detailed description
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.
Interventions
The 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.
Sponsors
Vesalius Cardiovascular Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - Number of Participants Experiencing All-Cause Mortality | 30 Days | 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 | Measured at Day 0 (Procedure Exit) | 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 | 30 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants by Mitral Regurgitation (MR) Severity Grade | 30 Days | 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) | 30 Days | Occurrence of serious cardiovascular, cerebrovascular, or renal events related to the device or procedure. |
Countries
Canada
Outcome results
None listed