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

NCT05739253 · tracked via the Priya Life Science China tracker

Sponsor

China National Center for Cardiovascular Diseases

Phase

Observational

Started

2022-03-22

Last updated

2025-02-10

Condition(s) studied

Aortic StenosisAscending Aortic DilatationBicuspid Aortic Valve

Investigational drug(s) / intervention(s)

Transcatheter aortic valve replacement

Transcatheter aortic valve replacement: All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Rate of ascending aortic dilatation — 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.

Trial sites (1)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05739253 on ClinicalTrials.gov ↗ ← All trials in China