Clinical trial Recruiting at 1 site Observational

Assessing changes in aortic diameter after valve replacement

Official title: Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement

Run by China National Center for Cardiovascular Diseases · NCT05739253 · Data updated 2026-11-12

This study looks at how the size of the aorta changes after patients have a heart valve replacement to see if it gets bigger or stays the same, especially for those who already had a larger aorta.

Quick facts

Study typeObservational
SexAll
Enrollment480 (estimated)
SponsorChina National Center for Cardiovascular Diseases
Government
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedMarch 22, 2022
Main results expectedMarch 21, 2025
Study endsMarch 21, 2025
Registry record updatedFebruary 10, 2025
Trial IDNCT05739253 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with severe aortic stenosis who are symptomatic and at high risk for surgical valve replacement.

Probably not a fit

Patients with dominant aortic regurgitation or those who have previously undergone aortic valve replacement or surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the changes in ascending aortic diameter in patients undergoing transcatheter aortic valve replacement (TAVR). It aims to determine whether the diameter increases or remains stable post-procedure, particularly in patients with pre-existing aortic dilatation. Additionally, the study seeks to identify factors that contribute to postoperative aortic dilatation. By refining risk stratification for TAVR candidates, this research could enhance patient outcomes.

Why it matters

Potential benefit: If successful, this study could improve risk assessment and management strategies for patients undergoing TAVR.

How similar studies have gone: While similar studies have explored aortic diameter changes, this specific focus on TAVR and its implications for aortic dilatation is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.