RecruitingNCT05739253

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


Sponsor

China National Center for Cardiovascular Diseases

Enrollment

480 participants

Start Date

Mar 22, 2022

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria4

  • 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 Criteria4

  • Dominant aortic regurgitation;
  • History of surgical or transcatheter aortic valve replacement;
  • History of aortic surgery;
  • Connective tissue disorders.

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Interventions

PROCEDURETranscatheter aortic valve replacement

All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis


Locations(1)

National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT05739253


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