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

Recruiting

• Conditions: Ascending Aortic Dilatation; Bicuspid Aortic Valve; Aortic Stenosis
• Interventions: Procedure: Transcatheter aortic valve replacement

• Registration Number: NCT05739253
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-03-22
• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-12
• Study First Posted: 2023-02-22
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-03-21
• Study Completion: 2025-03-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transfemoral TAVR for AS	Transcatheter aortic valve replacement	Patients undergoing transfemoral transcatheter aortic valve replacement for aortic stenosis

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Rate of all-cause mortality	1-year and 2-year	All-cause mortality during the follow-up period
Rate of adverse aortic events	1-year and 2-year	Aortic dissection, aortic rupture, and sudden death not attributable to other causes.

Trial Locations

Locations (1)

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