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

NCT07470788 | Not Yet Recruiting

• 1 other identifier: VES-CPT-002
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Mitral Regurgitation Severity

  30 Days

• Major Adverse Events (MAE)

  30 Days

Study Arms (1)

Vesalius TMVr System

EXPERIMENTAL

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

Interventions

Transcatheter Mitral Valve Repair DEVICE

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.

Vesalius TMVr System

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vesalius Cardiovascular Inc.: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)