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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06375590
Other study ID # 2024-NavIIcusp
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date May 1, 2026

Study information

Verified date April 2024
Source Clinique Pasteur
Contact Didier Tchétché, MD
Phone +33562211699
Email d.tchetche@clinique-pasteur.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date May 1, 2026
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years. 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: 1. Age < 18 years 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

Study Design


Intervention

Device:
Transcatheter Aortic Valve Implantation
Transcatheter treatment of bicuspid stenosis with the Navitor platform

Locations

Country Name City State
France Clinique Pasteur Toulouse Occitanie

Sponsors (2)

Lead Sponsor Collaborator
Didier TCHETCHE Abbott

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30-day device success (Rate) as indicated in the VARC-3 criteria 30-day
Secondary 1 year at least moderate bioprosthetic valve deterioration defined as increase in mean transvalvular gradient =10 mmHg resulting in mean gradient =20 mmHg with concomitant decrease in EOA =0.3 cm2 or =25% and/or decrease in Doppler velocity index =0.1 or =20% compared with echocardiographic assessment performed 1-3 months post-procedure, OR new occurrence or increase of =1 grade of intra-prosthetic AR resulting in = moderate AR 1-year
Secondary 1 year severe patient-prosthesis mismatch defined as EOAi < 0.65 cm2/m2 1-year
Secondary 30 days and 1 year all-cause and cardiovascular mortality 1-year
Secondary 30 days and 1 year stroke 1-year
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