Bicuspid Aortic Valve
Conditions
Keywords
Bicuspid aortic valve, TAVI, Navitor
Brief 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).
Interventions
DEVICETranscatheter Aortic Valve Implantation
Transcatheter treatment of bicuspid stenosis with the Navitor platform
Sponsors
Abbott
Didier TCHETCHE
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day device success (Rate) | 30-day | as indicated in the VARC-3 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1 year at least moderate bioprosthetic valve deterioration | 1-year | 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 severe patient-prosthesis mismatch | 1-year | defined as EOAi \< 0.65 cm2/m2 |
| 30 days and 1 year all-cause and cardiovascular mortality | 1-year | — |
| 30 days and 1 year stroke | 1-year | — |
Countries
France
Contacts
Primary ContactDidier Tchétché, MD
Outcome results
None listed