Feasibility of a new valve replacement for severe mitral regurgitation

HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)

This study is testing a new valve replacement for people with severe mitral regurgitation who can't have traditional surgery to see if it is safe and effective for them.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: HighLife SAS (Industry-sponsored)
• Locations: 14 sites (Auchenflower and 13 other locations)
• Trial ID: NCT04888247 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with moderate-severe or severe mitral regurgitation and classified as NYHA Class II-IV.

Not a fit: Patients with recent strokes, severe carotid stenosis, active infections, or significant bleeding disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a less invasive treatment option for patients with severe mitral regurgitation who are not suitable for open-heart surgery.

How similar studies have performed: Other studies have explored similar transcatheter approaches for mitral valve replacement, showing promising results, but this specific valve is novel.

Eligibility criteria

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 this trial is running

Auchenflower and 13 other locations

• Wesley Hospital — Auchenflower, Australia (Recruiting)
• Mount Hospital — Perth, Australia (Recruiting)
• Macquarie University Hospital — Sydney, Australia (Terminated)
• 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)
• CHU de Rennes — Rennes, France (Recruiting)
• Cliniue Pasteur — Toulouse, France (Recruiting)
• Deutsches Herzzentrum Munchen — Munich, Germany (Recruiting)
• University Hospital Ulm — Ulm, Germany (Recruiting)
• Medical University of Silesia — Katowice, Poland (Recruiting)
• Medical University of Warsaw — Warsaw, Poland (Recruiting)
• Brighton and Sussex University Hospital — Brighton, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Luc Verhees

Conditions Mitral Regurgitation