BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.

• Conditions: Bicuspid Aortic Valve

• Registration Number: NCT03495050
• Lead Sponsor: Clinique Pasteur

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-02-21
• Study First Submitted: 2018-03-03
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-10
• Last Update Posted: 2018-06-12
• Primary Completion: 2019-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Valve performance	one year	effective orifice area\<0.85 cm2/m2 and/or mean gradient\>20 mmHg and/or aortic regurgitation\>moderate

Secondary Outcome Measures

Name	Time	Method
mortality	30 days and one year
Patient-prosthesis mismatch	30 days and 1 year	indexed effective area \<0.65 cm2/m2
Ellipticity index at 30 days	30 days

Trial Locations

Locations (1)

Clinique Pasteur; 🇫🇷 Toulouse, Occitanie, France