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NCT Number: NCT05739253

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

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.

Recruiting

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Ascending Aortic Dilatation Bicuspid Aortic Valve Bicuspid Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Kang An, Dr

SUB_INVESTIGATOR

Xiangbin Pan, Dr

CONTACT

[email protected]

0086-010-88396666

Xiangbin Pan, Dr

PRINCIPAL_INVESTIGATOR

About this study

Ascending aortic (AA) dilatation occurs frequently in patients with aortic stenosis (AS). For patients who are candidates for transcatheter aortic valve replacement (TAVR), simultaneous repair of a dilatated AA is technically difficult. As the indications for TAVR have extended to low-risk patients and patients with bicuspid aortic valve , AA dilatation should be considered as a new criterion to refine risk stratification in patients undergoing TAVR. In this observational study, we aim to evaluate the changes of AA diameters and identify the determinants post-TAVR AA dilatation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcatheter aortic valve replacement

Procedure

All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis

Primary outcomes

  1. Rate of ascending aortic dilatation

    Time frame: 1-year and 2-year

    The change of AA diameters (before the procedure and at the latest follow-up) divided by the follow-up period.

Secondary outcomes

  1. Rate of all-cause mortality

    Time frame: 1-year and 2-year

    All-cause mortality during the follow-up period

  2. Rate of adverse aortic events

    Time frame: 1-year and 2-year

    Aortic dissection, aortic rupture, and sudden death not attributable to other causes.

Study contacts

Contact information is provided by the study sponsor or research team.

Kang An, Dr

CONTACT

[email protected]

0086-15801301740

Xiangbin Pan, Dr

CONTACT

[email protected]

0086-010-88396666

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2023
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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