NCT05739253

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 480 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis
• Ascending Aortic Dilatation
• Bicuspid Aortic Valve

Interventions

Type	Name	Description
PROCEDURE	Transcatheter aortic valve replacement	All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis

Timeline

• Start date: 2022-03-22
• Primary completion: 2025-03-21
• Completion: 2025-03-21
• First posted: 2023-02-22
• Last updated: 2025-02-10

Locations

1 site across 1 country: China