An observational study in Bicuspid Aortic Valve, sponsored by Clinique Pasteur. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Clinique Pasteur · Observational
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.
62 studies on the registry are indexed under Bicuspid Aortic Valve Disease; 21 are open to participants now.
This study's enrollment of 150 is below the median of 236 across 38 observational studies indexed under Bicuspid Aortic Valve Disease.
Browse Bicuspid Aortic Valve Disease studies →Clinique Pasteur is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform
Also known as: Transcatheter Aortic Valve Replacement
Valve performance
effective orifice area\<0.85 cm2/m2 and/or mean gradient\>20 mmHg and/or aortic regurgitation\>moderate
Time frame: 30 days
Valve performance
effective orifice area\<0.85 cm2/m2 and/or mean gradient\>20 mmHg and/or aortic regurgitation\>moderate
Time frame: one year
mortality
Time frame: 30 days and one year
Patient-prosthesis mismatch
indexed effective area \<0.65 cm2/m2
Time frame: 30 days and 1 year
Ellipticity index at 30 days
Time frame: 30 days
Plan to share: Undecided — Mutual ananymized database. Substudies anticipated.
Ran from Jun 2018 to primary completion in Feb 2020, 20 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Bicuspid Aortic Valve Disease →
Clinique Pasteur