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Completed

NCT Number: NCT03495050

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.

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Key information

Conditions

Bicuspid Aortic Valve Aortic Valve Disease Bicuspid Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Pasteur

Toulouse, Occitanie, 31076, France

About this study

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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcatheter aortic valve implantation

Device

Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform

Other names: Transcatheter Aortic Valve Replacement

Primary outcomes

  1. Valve performance

    Time frame: 30 days

    effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate

  2. Valve performance

    Time frame: one year

    effective orifice area<0.85 cm2/m2 and/or mean gradient>20 mmHg and/or aortic regurgitation>moderate

Secondary outcomes

  1. mortality

    Time frame: 30 days and one year

  2. Patient-prosthesis mismatch

    Time frame: 30 days and 1 year

    indexed effective area <0.65 cm2/m2

  3. Ellipticity index at 30 days

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Registry information

Acronym: BIVOLUTX

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 11, 2018
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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