Recruiting

Vesalius TMVr System

Sponsor:

Vesalius Cardiovascular Inc.

Code:

NCT07470788

Conditions

Degenerative Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Transcatheter Mitral Valve Repair

Study Details

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.

Conditions

Degenerative Mitral Regurgitation

Study ID

NCT07470788

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2032

Anticipated

Primary completion date

Apr, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Vesalius TMVr System

Participants in this arm will undergo implantation with the Vesalius Transcatheter Mitral Valve Repair (TMVr) System according to the study protocol. All procedures will be performed by trained interventional cardiologists, and participants will be followed for safety, device performance, and clinical outcomes at predefined intervals.

Interventions

Transcatheter Mitral Valve Repair

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.

Primary outcome measure

  • Safety - Number of Participants Experiencing All-Cause Mortality [ Time Frame: 30 Days ]
  • Number of Participants Achieving Technical Success [ Time Frame: Measured at Day 0 (Procedure Exit) ]
  • Number of participants Achieving Device Success [ Time Frame: 30 Days ]

Central Contacts and Locations

Locations

St. Paul's Hospital

Recruiting

Vancouver, Canada

Contacts

Elizabeth Grieve

604-682-2344elizabeth.grieve@phc.ca

More Information

Sponsor

Vesalius Cardiovascular Inc.

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vesalius Cardiovascular Inc. on 2026-08-19.