Feasibility of a new 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 study evaluates the feasibility, safety, and performance of the HighLife CLARITY trans-septal mitral valve replacement (TSMVR) in patients with moderate to severe mitral regurgitation who are at high risk for traditional surgical interventions. It focuses on patients classified as NYHA Class II to IV and assesses their eligibility based on a multidisciplinary Heart Team's evaluation. The study aims to determine the effectiveness of the CLARITY valve and its delivery system in this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Moderate-severe or severe mitral regurgitation (≥ 3+)
3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
4. Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability
6. Patient meets the anatomical criteria for HighLife valve
7. Patient is willing to participate in the study and provides signed informed consent
8. Patients with a high risk for LVOTO

Exclusion Criteria:

1. Any stroke/TIA within 30 days
2. Severe symptomatic carotid stenosis (\> 70% by non-invasive imaging)
3. Active infections requiring antibiotic therapy
4. Active ulcer or gastro-intestinal bleeding in the past 3 months
5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
6. Patients in whom TEE is not feasible
7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
8. Patient is unable to comply with the follow-up schedule and assessments
9. Participation in another clinical investigation at the time of inclusion
10. Patient has known allergies to the device components or contrast medium
11. Patient cannot tolerate anticoagulation or antiplatelet therapy
12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions
13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months

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Where it's running

• Wesley Hospital
  Auchenflower, Australia Recruiting
• Mount Hospital
  Perth, Australia Recruiting
• AZ St. Jan - Brugge
  Bruges, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• CHU Lille
  Lille, France Recruiting
• Centre Hospitalo - Univ de Nantes
  Nantes, France Recruiting

Study contacts

• Study coordinator: Luc Verhees
• Email: lverhees@highlifemed.com
• Phone: +31 6 4270 2457

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.