Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- China National Center for Cardiovascular Diseases
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Rate of ascending aortic dilatation
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Rate of ascending aortic dilatation
Time Frame: 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 Outcomes
- Rate of all-cause mortality(1-year and 2-year)
- Rate of adverse aortic events(1-year and 2-year)