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Recruiting NCT05739253

Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement

Trial Parameters

Condition Aortic Stenosis
Sponsor China National Center for Cardiovascular Diseases
Study Type OBSERVATIONAL
Phase N/A
Enrollment 480
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2022-03-22
Completion 2025-03-21
Interventions
Transcatheter aortic valve replacement

Brief Summary

The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are: 1. whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation; 2. the determinants of postoperative ascending aortic dilatation.

Eligibility Criteria

Inclusion Criteria: * Severe aortic stenosis defined as an aortic valve area of 1cm2 or less or an indexed aortic valve area of 0.6cm2/m2 or less; * Presence of clinical symptoms defined as a New York Heart Association functional class of 2 or more; * High risk of surgical aortic valve replacement; * Suitability for a transfemoral vascular access. Exclusion Criteria: * Dominant aortic regurgitation; * History of surgical or transcatheter aortic valve replacement; * History of aortic surgery; * Connective tissue disorders.

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