Bicuspid Aortic Valve Clinical Trial
Official title:
BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.
Study Design Study Design: prospective non-interventional multicenter registry Screening:
MSCT submitted to core lab & sizing strategy pre-declared (annular sizing, supra-annular
sizing, mix of both methods) Follow up: MSCT and TTE to cooper lab
TAVI treatment Predilatation according to aortic annulus Dmin Evolut Pro (23-26-29) and
Evolut R 34 XL Annular anchoring of the THV Postdilatation according to the operators'
discretion Study Population All consecutive patients presenting with severe and symptomatic
bicuspid aortic valve stenosis or mixed disease
Inclusion Criteria 1. Age ≥18 years. 2. NYHA≥2 and/or syncope and/or angina. 3. Patient
judged by the Heart Team as indicated for TAVI. 4. Anatomical suitability for
transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment.
5. 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 Evolut Pro or XL. 8. Unsuitable peripheral vasculature for
transfemoral Evolut Pro or XL. Primary Endpoint Valve performane Secondary endpoints 30 day
and 1 year mortality Patient-prosthesis mismatch Ellipticity index at 30 days Follow-up 30
days: physical examination, ECG, TTE /MSCT upon operators' judgement
1 year: physical examination, ECG, TTE.
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