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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Stenosis; Bicuspid Aortic Valve; Ascending Aortic Dilatation
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 480

Contacts and Locations

• Study Contact: Name: Xiangbin Pan, Dr; Phone Number: 0086-010-88396666; Email: panxiangbin@fuwaihospital.org
• Study Contact Backup: Name: Kang An, Dr; Phone Number: 0086-15801301740; Email: ankang913@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
      • Contact: Xiangbin Pan, Dr; Phone Number: 0086-010-88396666; Email: panxiangbin@fuwaihospital.org
      • Principal Investigator: Xiangbin Pan, Dr
      • Sub-Investigator: Kang An, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The indication to perform transcatheter aortic valve replacement was based on a consensus by the Institutional Heart Team.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of ascending aortic dilatation	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Estimated): March 21, 2025
• Study Completion (Estimated): March 21, 2025

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: February 12, 2023
• First Posted (Actual): February 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Bicuspid aortic valve; Transcatheter aortic valve replacement; Ascending aortic diameter; Ascending aortic dilatation
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Bicuspid Aortic Valve Disease; Aortic Valve Stenosis; Dilatation, Pathologic
• Other Study ID Numbers: 2021-1602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No