BIVOLUTX: Bicuspid Aortic Stenosis With Evolut Platform International Experience.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-21

Study Completion Date

2020-05-31

Brief Summary

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

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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.

Conditions

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Bicuspid Aortic Valve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transcatheter Aortic Valve Implantation

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

Intervention Type DEVICE

Other Intervention Names

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Transcatheter Aortic Valve Replacement

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No