CompletedNot Applicable

The CASPER Registry

Italy100 participantsStarted 2021-07-01

Plain-language summary

The CASPER study is a prospective, international, multicenter registry which aims to evaluate the use of an algorithm for choosing the size of the prosthesis to be implanted in patients with bicuspid aortic stenosis type I treated by TAVI with Evolut® Pro prostheses (23 -26-29) and Evolut® R 34.

Who can participate

Age range18 Years

SexALL

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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 or any alternative access TAVI, based on MSCT assessment and local expertise and preference.
✓. Estimated life expectancy\>1 year.

Exclusion criteria

✕. Age \<18 years
✕. Estimated life expectancy\<1 year
✕. Pure aortic regurgitation.
✕. LVEF\<20%
✕. No baseline MSCT evaluation.

What they're measuring

Efficacy of the CASPER algorithm

Timeframe: 1 year

Trial details

NCT IDNCT04817735

SponsorUniversity of Pisa

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Bicuspid Aortic Valve trials