HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
NCT ID: NCT04888247
Last Updated: 2024-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2021-07-01
2031-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Trans-septal mitral valve replacement
CLARITY
Trans-septal mitral valve replacement
Interventions
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CLARITY
Trans-septal mitral valve replacement
Eligibility Criteria
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Inclusion Criteria
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
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
\-
18 Years
ALL
No
Sponsors
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HighLife SAS
INDUSTRY
Responsible Party
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Locations
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Wesley Hospital
Auchenflower, , Australia
Mount Hospital
Perth, , Australia
Macquarie University Hospital
Sydney, , Australia
AZ St. Jan - Brugge
Bruges, , Belgium
UZ Leuven
Leuven, , Belgium
CHU Lille
Lille, , France
Centre Hospitalo - Univ de Nantes
Nantes, , France
CHU de Rennes
Rennes, , France
Cliniue Pasteur
Toulouse, , France
Deutsches Herzzentrum Munchen
Munich, , Germany
University Hospital Ulm
Ulm, , Germany
Medical University of Silesia
Katowice, , Poland
Medical University of Warsaw
Warsaw, , Poland
Brighton and Sussex University Hospital
Brighton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Anthony Camuglia, MD
Role: primary
Jan van der Heyden, MD
Role: primary
Christophe Dubois, MD
Role: primary
Guillaume Leurent, MD
Role: primary
Michael Joner, MD
Role: primary
Wolfgang Rottbauer, MD
Role: primary
Wojciech Wojakowski, MD
Role: primary
Zenon Huczek, MD
Role: primary
David Hildick-Smith, MD
Role: primary
Other Identifiers
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HL-2021-01
Identifier Type: -
Identifier Source: org_study_id
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