HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

Recruiting now · Not applicable

Conditions studied: Mitral Regurgitation

In brief

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system

Key facts

Study ID

NCT04888247

Run by

HighLife SAS

People needed

30

Starts

2021-07-01

Expected to finish

2031-02-01

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Moderate-severe or severe mitral regurgitation (≥ 3+)
• Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
• Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
• 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
• Patient meets the anatomical criteria for HighLife valve
• Patient is willing to participate in the study and provides signed informed consent
• Patients with a high risk for LVOTO

You may not qualify if…

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

Where it is running

• Brighton and Sussex University Hospital — Brighton, United Kingdom (enrolling)
• Mount Hospital — Perth, Australia (enrolling)
• Wesley Hospital — Auchenflower, Australia (enrolling)
• AZ St. Jan - Brugge — Bruges, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• CHU Lille — Lille, France (enrolling)
• Centre Hospitalo - Univ de Nantes — Nantes, France (enrolling)
• CHU de Rennes — Rennes, France (enrolling)
• Cliniue Pasteur — Toulouse, France (enrolling)
• Deutsches Herzzentrum Munchen — Munich, Germany (enrolling)
• University Hospital Ulm — Ulm, Germany (enrolling)
• Medical University of Silesia — Katowice, Poland (enrolling)
• Medical University of Warsaw — Warsaw, Poland (enrolling)
• Macquarie University Hospital — Sydney, Australia

Full record on ClinicalTrials.gov

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