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

N/ANot Yet RecruitingNCT07470788

Vesalius Cardiovascular Inc.5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Degenerative Mitral Regurgitation

Interventions

Transcatheter Mitral Valve RepairDEVICE

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Paul's Hospital

Vancouver, Canada

Outcomes

Primary Outcomes

Vesalius TMVr System Safety

Number of deaths from any cause occurring post-implant, at hospital discharge, and at 30 days.

Time frame: 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.

Time frame: 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.

Time frame: 30 Days

Secondary Outcomes

Mitral Regurgitation Severity

Assessment of mitral regurgitation severity using echocardiography at follow-up visits.

Time frame: 30 Days

Major Adverse Events (MAE)

Occurrence of serious cardiovascular, cerebrovascular, or renal events related to the device or procedure.

Time frame: 30 Days

Data from ClinicalTrials.gov

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