Transcatheter Mitral Valve Replacement for Severe Mitral Regurgitation

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 trial evaluates the safety and efficacy of the Medtronic Intrepid™ transcatheter mitral valve replacement system in patients suffering from severe symptomatic mitral regurgitation. It is a prospective, single-arm, multi-center interventional trial designed for individuals who are deemed unsuitable for existing treatment options. The study aims to provide a new therapeutic approach for patients with specific heart valve conditions, particularly those with moderate-to-severe symptoms or combined mitral stenosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject has moderate-to-severe or severe symptomatic mitral regurgitation as defined by the American Society of Echocardiography 2017 Guidelines and Standards - Recommendations for Non-invasive Evaluation of Native Valvular Regurgitation, or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of MAC
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that patient is unsuitable for treatment with approved transcatheter repair or conventional mitral valve surgery
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
* Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
* Subjects anatomically suitable for the Medtronic Intrepid™ TMVR TF System

Exclusion Criteria:

* Estimated life expectancy of less than 24 months
* Currently surgically implanted mitral valve
* Prior transcatheter mitral valve procedure with device currently implanted
* Anatomic contraindications
* Anatomically prohibitive mitral annular calcification (MAC)
* Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
* LVEF \< 25% (measured by resting transthoracic echocardiogram), patients with LVEF 25 - \<30% will be further evaluated by the Screening Committee for approval (Right Ventricular Dysfunction, pulmonary hypertension, and left ventricular function)
* Left ventricular end diastolic diameter (LVEDD) \> 75mm
* Need for emergent or urgent surgery
* Hemodynamic instability
* History of bleeding diathesis or coagulopathy
* End stage renal disease
* Liver failure
* Frailty

Where it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Clinique Pasteur
  Toulouse, Cedex 03, France Recruiting
• CHU Bordeaux
  Bordeaux, Pessac Cedex, France Recruiting
• Henri-Mondor University Hospital
  Créteil, France Recruiting

Study contacts

• Principal investigator: Thomas Modine, Prof. — University Hospital, Bordeaux
• Study coordinator: Hanne Gonnissen, PhD
• Email: rs.apolloeurope@medtronic.com
• Phone: +31 (0)43 356 6566

Similar studies

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

• 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

• Outcomes after new edge-to-edge mitral valve repair

  This project will follow people with mitral regurgitation who receive transcatheter edge-to-edge repair at Amsterdam UMC to see how they do long-term and whether patient selection can be improved.

  Recruiting Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam, North Holland · NCT07108907

• Surgical implantation of a polymer prosthetic mitral or aortic valve

  This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.

  Recruiting Mitrassist Lifesciences Limited Co., Ltd. · Shanghai, Shanghai Municipality · NCT07097740

• GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation

  This trial will try the GeminiOne TEER system to treat adults with severe, symptomatic mitral regurgitation who are high surgical risk or have not improved with medical therapy.

  Recruiting Sierra Valve LLC · Thousand Oaks, California · NCT07086534

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.