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.

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Mitral Regurgitation
• Intervention / Treatment: Device: Transcatheter Mitral Valve Repair

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.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Vancouver, Canada
    • St. Paul's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vesalius TMVr System Safety	Number of deaths from any cause occurring post-implant, at hospital discharge, and at 30 days.	30 Days
Vesalius TMVr Technical Success	Successful deployment and correct positioning of the first intended device, absence of procedural mortality, and freedom from emergency surgery or reintervention at the end of the procedure.	Measured at Day 0 (Procedure Exit)
Vesalius TMVr Device Success	Proper placement and positioning of the device, absence of procedural mortality or stroke, freedom from unplanned surgery or intervention, and continued intended device safety and function.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mitral Regurgitation Severity	Assessment of mitral regurgitation severity using echocardiography at follow-up visits.	30 Days
Major Adverse Events (MAE)	Occurrence of serious cardiovascular, cerebrovascular, or renal events related to the device or procedure.	30 Days

Collaborators and Investigators

• Sponsor: Vesalius Cardiovascular Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: VES-CPT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No