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

Aortic Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05739253
• Other study ID #: 2021-1602
• Status: Recruiting
• Start date: March 22, 2022
• Est. completion date: March 21, 2025

Study information

• Verified date: February 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Xiangbin Pan, Dr
• Phone: 0086-010-88396666
• Email: panxiangbin[@]fuwaihospital.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: March 21, 2025
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Bicuspid Aortic Valve
• Bicuspid Aortic Valve Disease

Intervention

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

Locations

Country	Name	City	State
China	National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ascending aortic dilatation rate	The change of AA diameters (before the procedure and at the latest follow-up) divided by the follow-up period.	1-year and 2-year
Secondary	All-cause mortality	All-cause mortality during the follow-up period	1-year and 2-year
Secondary	Adverse aortic events	Aortic dissection, aortic rupture, and sudden death not attributable to other causes.	1-year and 2-year