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).
Study Type
OBSERVATIONAL
Enrollment
150
Transcatheter treatment of bicuspid stenosis with the Navitor platform
Clinique Pasteur
Toulouse, Occitanie, France
30-day device success (Rate)
as indicated in the VARC-3 criteria
Time frame: 30-day
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
Time frame: 1-year
1 year severe patient-prosthesis mismatch
defined as EOAi \< 0.65 cm2/m2
Time frame: 1-year
30 days and 1 year all-cause and cardiovascular mortality
Time frame: 1-year
30 days and 1 year stroke
Time frame: 1-year
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