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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04817735
Other study ID # PI-2021-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2021
Est. completion date March 30, 2023

Study information

Verified date May 2022
Source University of Pisa
Contact Anna Sonia Petronio, M.D.
Phone +39050995326
Email as.petronio@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Procedure:
TAVI
TAVI sizing with dedicated algorithm

Locations

Country Name City State
Italy Azienda Ospedaliero Universitaria Pisana Pisa

Sponsors (1)

Lead Sponsor Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of the CASPER algorithm The objective of the study is to validate the CASPER algorithm in a prospective cohort using a self-expandable THV, in order to assess the safety and efficacy of bicuspid aortic valve sizing based on calcium burden and raphe length. 1 year
Secondary Safety of the CASPER algorithm To assess valve performance in terms of prosthesis mismatch and valve dysfunction (clinical features), and post-procedural CT assessment of the prosthesis behavior. 1 year
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