BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.

Study Overview
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Brief Summary
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Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.

Detailed Description
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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.

Official Title
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BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.

Conditions
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Bicuspid Aortic Valve

Intervention / Treatment
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* Device: Transcatheter Aortic Valve Implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years. NYHA≥2 and/or syncope and/or angina. Patient judged by the Heart Team as indicated for TAVI. Anatomical suitability for transfemoral-TAVI with Evolut Pro or Evolut R XL, based on MSCT assessment. Estimated life-expectancy>1 year. Exclusion Criteria: Age <18 years Asymptomatic patients Estimated life expectancy<1 year Pure aortic regurgitation. LVEF<20% No baseline MSCT evaluation. Unsuitable aortic root anatomy for Evolut Pro or XL. Unsuitable peripheral vasculature for transfemoral Evolut Pro or XL.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcatheter Aortic Valve Implantation|Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valve performance | effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate | 30 days | 
| Valve performance | effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 30 days and one year | 
| Patient-prosthesis mismatch | indexed effective area <0.65 cm2/m2 | 30 days and 1 year | 
| Ellipticity index at 30 days |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bicuspid, TAVI, TAVR, self-expanding, Evolut