NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
NCT ID: NCT06375590
Last Updated: 2024-04-19
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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NOT_YET_RECRUITING
150 participants
OBSERVATIONAL
2024-05-01
2026-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bicuspid aortic valve
Treated with Navitor platform
Transcatheter Aortic Valve Implantation
Transcatheter treatment of bicuspid stenosis with the Navitor platform
Interventions
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Transcatheter Aortic Valve Implantation
Transcatheter treatment of bicuspid stenosis with the Navitor platform
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. NYHA ≥ 2 and/or syncope and/or angina.
3. Symptomatic severe calcified aortic stenosis with AVA \< 1 cm2 AND peak velocity \> 4 m/s or mean gradient \> 40 mmHg or DVI \< 0.25'.
4. Patient judged by the Heart Team as indicated for TAVI.
5. Anatomical suitability for transfemoral-TAVI with Navitor, based on MSCT assessment.
6. Estimated life-expectancy \> 1 year.
Exclusion Criteria
2. Asymptomatic patients
3. Estimated life expectancy \< 1 year
4. Pure aortic regurgitation.
5. LVEF \< 20%
6. No baseline MSCT evaluation.
7. Unsuitable aortic root anatomy for Navitor.
8. Unsuitable peripheral vasculature for transfemoral Navitor.
9. Type 2 bicuspid aortic valve
10. Excessive leaflet calcifications
11. Moderate or severe raphe calcifications
12. Severe LVOT calcifications
13. Perimeter-derived annular dimension exceeding IFU recommendation
14. Dilated ascending aorta \>45 mm
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Didier TCHETCHE
OTHER
Responsible Party
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Didier TCHETCHE
Head of structural heart disease program
Principal Investigators
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Didier Tchétché, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Pasteur
Locations
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Clinique Pasteur
Toulouse, Occitanie, France
Countries
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Central Contacts
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Facility Contacts
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Didier Tchétché, MD
Role: primary
Other Identifiers
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2024-NavIIcusp
Identifier Type: -
Identifier Source: org_study_id
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