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

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT05739253

Collaborator

(none)

480

Enrollment

Location

Anticipated Duration (Months)

13.3

Patients Per Site Per Month

Study Details

Study Description

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:

whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation;
the determinants of postoperative ascending aortic dilatation.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis Ascending Aortic Dilatation Bicuspid Aortic Valve	Procedure: Transcatheter aortic valve replacement

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 Design

Study Type:

Observational

Anticipated Enrollment :

480 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 22, 2022

Anticipated Primary Completion Date :

Mar 21, 2024

Anticipated Study Completion Date :

Mar 21, 2025

Arms and Interventions

Arm	Intervention/Treatment
Transfemoral TAVR for AS Patients undergoing transfemoral transcatheter aortic valve replacement for aortic stenosis	Procedure: Transcatheter aortic valve replacement All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis

Arm

Intervention/Treatment

Transfemoral TAVR for AS

Patients undergoing transfemoral transcatheter aortic valve replacement for aortic stenosis

Procedure: Transcatheter aortic valve replacement

All patients undergo transfemoral transcatheter aortic valve replacement for aortic stenosis

Outcome Measures

Primary Outcome Measures

Ascending aortic dilatation rate [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

All-cause mortality [1-year and 2-year]
All-cause mortality during the follow-up period
Adverse aortic events [1-year and 2-year]
Aortic dissection, aortic rupture, and sudden death not attributable to other causes.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing	Beijing	China	100037