Clinical trial NCT03495050: BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Official title: BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bicuspid Aortic Valve
Keywords: Bicuspid
TAVI
TAVR
self-expanding
Evolut
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease

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.

Eligibility criteria: 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 outcomes:
measure: Valve performance
timeFrame: 30 days
measure: Valve performance
timeFrame: one year
Secondary outcomes:
measure: mortality
timeFrame: 30 days and one year
measure: Patient-prosthesis mismatch
timeFrame: 30 days and 1 year
measure: Ellipticity index at 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
state: Occitanie
Study officials:
References:
citation: Tchetche D, de Biase C, van Gils L, Parma R, Ochala A, Lefevre T, Hovasse T, De Backer O, Sondergaard L, Bleiziffer S, Lange R, Kornowski R, Landes U, Norgaard BL, Biasco L, Philippart R, Molina-Martin de Nicolas J, Mylotte D, Lemee C, Dumonteil N, Van Mieghem NM. Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry. Circ Cardiovasc Interv. 2019 Jan;12(1):e007107. doi: 10.1161/CIRCINTERVENTIONS.118.007107.