Vesalius TMVr System for Degenerative Mitral Regurgitation in high-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, interventional study enrolling up to five patients in Canada to evaluate the safety and performance of the Vesalius TMVr System for symptomatic degenerative MR in those at elevated surgical risk. Procedures involve transcatheter implantation with short- and mid-term follow-up to assess procedural success, device performance, and adverse events using MVARC definitions. Outcomes include safety, valve function, hemodynamics, and clinical status over a follow-up period. The study aims to generate preliminary data to inform further development and larger trials. Eligible participants have moderate-to-severe or severe degenerative MR and adequate anatomy for the Vesalius system, with follow-up planned for up to five years.

Why it matters

Who can join: the full rules

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

Where it's running

• St. Paul's Hospital
  Vancouver, Canada Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mitral valve repair with the CathHELIX transcatheter annuloplasty system for functional mitral regurgitation

  This will test the CathHELIX transcatheter mitral annuloplasty device to see if it reduces moderate-to-severe or severe functional mitral regurgitation and improves symptoms in adults with NYHA class II–IV and LVEF ≥30%.

  Recruiting at 2 sites HVR Cardio Oy · Tbilisi, Georgia and 1 other locations · NCT07188233

• Innovalve mitral valve replacement system evaluation

  This study is testing a new mitral valve replacement system to see if it is safe and works well for patients with severe mitral valve leakage.

  Recruiting at 19 sites Edwards Lifesciences · Los Angeles, California and 20 other locations · NCT04919980

• Comparing early mitral valve repair to watchful waiting for asymptomatic severe mitral regurgitation

  This study is testing if early surgery for the mitral valve can help people with severe mitral regurgitation live longer and healthier compared to just keeping an eye on their condition.

  Recruiting at 2 sites Centre Hospitalier Universitaire, Amiens · Amiens and 1 other locations · NCT03389542

• Posterior Mitral Leaflet Replacement to Reduce Mitral Regurgitation

  This early feasibility trial tests the MR-ace Implant and Delivery System to see if it can reduce symptoms and leaks in people with moderate-to-severe functional mitral regurgitation.

  Recruiting Polares Medical SA · Atlanta, Georgia and 2 other locations · NCT07517588

• Replacing the native mitral valve with the ReValve System

  This study will test whether replacing the native mitral valve with the ReValve System helps adults with symptomatic, clinically significant mitral regurgitation who are appropriate candidates for mitral valve surgery.

  Recruiting at 3 sites Phase 1 ReValve Solutions Inc. · Tbilisi and 2 other locations · NCT07450911

• Mitral valve replacement with the SATURN TMVR system for severe mitral regurgitation

  This study tests whether the SATURN TS transcatheter mitral valve replacement can be safely implanted and work well in adults with severe mitral regurgitation who are high-risk for open-heart surgery.

  Recruiting at 2 sites InnovHeart · Los Angeles, California and 4 other locations · NCT07130994

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.